Production Associate

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com. Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Title: Welder Location: Waterloo, Iowa Salary: $23-26/hour  Job Summary of the Welder: We are looking to hire 2 Full-Time Experienced Welders who can read blueprints.  Job Duties & Responsibilities of the Welder: ·        Operate various pieces of equipment, including hand plasma, saws, brake press, and deburring equipment. ·        Weld quality parts set by blueprint specifications using jigs when available, while meeting production standard times. ·        Keep work area clean and organized. ·        Be safe in all operations of the job.  Requirements  Education & Experience Requirements of the Welder: ·        Requires a High School degree or GED. ·        1+ years of experience working in a manufacturing environment. ·        Ability to read blueprints. ·        Must be able to layout parts and fabricate as needed. ·        Requires an on-site weld test prior to placement. (Mig) ·        Proficient in measuring and calculating fractions, decimals, and angles. ·        Must be able to utilize various measurement tools, including but not limited to square, angle square, calipers, tape measure (to 1/32”). ·        Use of wrenches, air tools, hand-held grinders, overhead cranes, steel handling and lifting skills. ·        Forklift experience or ability to train on the operation of a forklift.

Prince Service & Manufacturing is seeking a skilled and detail-oriented Applications Engineer to support our manufacturing operation. This role focuses on evaluating production methods, creating & optimizing machine programs, improving tooling selection, and implementing process improvements that increase productivity, quality, and efficiency across our cutting operations. The ideal candidate will have strong technical expertise in sheet metal cutting, forming, fabrication, and industrial machinery, with the ability to collaborate closely with production, engineering, and quality teams to ensure seamless manufacturing workflows.  Who We Are:  Founded in 1965, Prince Service & Mfg. has been synonymous with quality work for more than 55 years. From our humble beginnings, to where we are today, serving our customers with superior products has been an unchanging goal for us. Our approach has been passed down through generations, and we are proud to serve both our customers and employees with a foundation in our core values. Without satisfied employees, we can’t serve our customers with the selfless care, ethical nature, and overall integrity we promise. We are proud to maintain an employee-focused company, where our team members feel supported and excited to come to work. We want your confidence and determination to shine in all you do - join our team today!     Location/Schedule: Macon, GA / 1st shift  What You’ll Do:  Develop, test, and optimize machine programs for Trumpf & Mitsubishi sheet metal fabrication equipment and automation systems  Collaborate with production teams to evaluate part designs for manufacturability and implement modifications that improve efficiency and reduce waste.  Analyze tooling needs, recommend standard or custom solutions, and maintain accurate tooling records.  Maintain complete and accurate technical documentation, process parameters, and work instructions.  Provide training and technical guidance to machine operators and setup personnel on programming, tooling, and best practices.  Collaborate with engineering, continuous improvement, and quality teams to troubleshoot application-related issues and ensure consistent part quality.  Support preventative maintenance efforts by developing and updating machine-specific technical guidelines and ensuring daily maintenance is completed.  Keep current with new manufacturing technologies, equipment capabilities, and software updates that could benefit production.  **We kindly ask that applicants refrain from contacting the company directly regarding application status. All updates will be provided through the recruiting team.**  Prince Service & Manufacturing is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.  Requirements Who You Are:  Bachelor’s degree in Engineering, Manufacturing Technology, or related field preferred; equivalent experience will be considered.  3+ years of experience in applications engineering, manufacturing engineering, or CNC programming.  Proficiency in CAD/CAM software, CNC machine programming, and sheet metal fabrication processes. Trumpf experience preferred.  Strong knowledge of tooling selection, material behavior, and machine setup for laser cutting, punching, and press brake operations.  Excellent problem-solving skills with a hands-on, collaborative approach.  Strong organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.  Benefits What We Offer:  Excellent Compensation   Medical, Dental, & Vision Insurance   Health Savings Account   Life & Disability Insurance   Employee Assistance Program   Team Meetings    Employee Committees & Involvement   Bonus Incentive Program   Community Service Day   Team Events & Activities   Awesome Company Culture 

The Class B CDL Driver is responsible for driving a tractor trailer or straight truck interstate reefer, on both city and highway routes, to deliver our seafood product to customers. They also assist with product delivery pick-up from the airport and will help transport product between company locations. The Class B CDL Driver is expected to complete all routes safely and in-accordance with Department of Transportation regulation and North Coast company policy. The Class B CDL Driver communicates and interacts with customers, vendors and co-workers. This requires them to present professionally and ensure company custom service practices and methods are executed accordingly. This position is paid hourly and eligible for overtime. This position would cover Thursday-Monday shifts mostly. This position reports to the Logistics Manager. DUTIES AND RESPONSIBILITIES Operate tractor trailers carrying loads over 10,000 pounds Inspects cargo loads to ensure that they are packed appropriately Deliver product to specific locations on scheduled route Ensure products are delivered in a timely manner Load and organize product inventory from warehouse into your vehicle and unload products in and out of truck as needed throughout the day Follow rules and regulations of the road at all times. Follow all company and state enforced safety requirements for loading and unloading product Scan or write in confirmation of delivery upon arrival to recipient client Collect signature at delivery locations Requirements 3+ years, experience tractor trailer driving, verifiable 1+ years, experience city driving Experience in food manufacturing; seafood or meat processing a plus Must be willing to work through the weekend Must be able to pass a DOT physical Class B Driver’s License, required Experience using hand trucks, pallet jacks and forklifts a plus Proficient at driving and parking tractor trailers Proficient at driving tractor trailers in the city Able to provide excellent customer service Able to maintain an environment that drives performance and a safe workplace Drive an environment of teamwork and open communication ADDITIONAL REQUIREMENTS Must be able to lift 30-50 pounds Work up to a 10-hour workday: standing/walking most of the day Hand use: single grasping, fine manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: Ability to work in wet and dry conditions Ability to work Monday-Friday, weekends when needed Ability to use tools and equipment, including knives North Coast Seafoods is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status. Benefits At North Coast, employees are considered part of a family where everyone works together to ensure the founding mission and values of the company are upheld every day. We offer an inclusive work environment spearheaded by an approachable leadership team who believes in the idea that it’s not just about the work we do, it’s about what the work allows us to do for our loved ones. We foster the opportunity for real growth and long-term employment. Most members of our leadership team started out on the floor and through mentorship advanced into their current roles. We are currently looking to build the next generation of leaders. We offer competitive compensation packages including comprehensive health care coverage, vacation and 401(k) to all full-time benefit-eligible employees. Employees also have access to the highest quality seafood at cost.

The Class A CDL Driver is responsible for driving a tractor trailer or straight truck interstate reefer, on both city and highway routes, to deliver our seafood product to customers. They also assist with product delivery pick-up from the airport and will help transport product between company locations. The Class A CDL Driver is expected to complete all routes safely and in-accordance with Department of Transportation regulation and North Coast company policy. The Class A CDL Driver communicates and interacts with customers, vendors and co-workers. This requires them to present professionally and ensure company custom service practices and methods are executed accordingly. This position is paid hourly and eligible for overtime. This position reports to the Logistics Manager. DUTIES AND RESPONSIBILITIES Operate 53-foot tractor trailers Inspects cargo loads to ensure that they are packed appropriately Deliver product to specific locations on scheduled route Ensure products are delivered in a timely manner Load and organize product inventory from warehouse into your vehicle and unload products in and out of truck as needed throughout the day Follow rules and regulations of the road at all times. Follow all company and state enforced safety requirements for loading and unloading product Scan or write in confirmation of delivery upon arrival to recipient client Collect signature at delivery locations Requirements 3+ years, experience tractor trailer driving, verifiable 1+ years, experience city driving Experience in food manufacturing; seafood or meat processing a plus Must be able to pass a DOT physical Class A Driver’s License, required Experience using hand trucks, pallet jacks and forklifts a plus Proficient at driving and parking tractor trailers Proficient at driving tractor trailers in the city Able to provide excellent customer service Able to maintain an environment that drives performance and a safe workplace Drive an environment of teamwork and open communication ADDITIONAL REQUIREMENTS Must be able to lift 30-50 pounds Work up to a 10-hour workday: standing/walking most of the day Hand use: single grasping, fine manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: Ability to work in wet and dry conditions Ability to work Monday-Friday, weekends when needed Ability to use tools and equipment, including knives North Coast Seafoods is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status. Benefits At North Coast, employees are considered part of a family where everyone works together to ensure the founding mission and values of the company are upheld every day. We offer an inclusive work environment spearheaded by an approachable leadership team who believes in the idea that it’s not just about the work we do, it’s about what the work allows us to do for our loved ones. We foster the opportunity for real growth and long-term employment. Most members of our leadership team started out on the floor and through mentorship advanced into their current roles. We are currently looking to build the next generation of leaders. We offer competitive compensation packages including comprehensive health care coverage, vacation and 401(k) to all full-time benefit-eligible employees. Employees also have access to the highest quality seafood at cost.

The Senior Inspector performs receiving, in-process, and final inspection on electronic systems, electromechanical assemblies, or mechanical assemblies and subassemblies. Accepts, rejects, or reworks defective units or systems. Determines or assists in determining methods, sequences, and procedures necessary for inspection. The position requires communication between production, project management, shipping/receiving, and quality management. Duties and Responsibilities: Perform all tests, inspections, and measurements required by pre-defined instruction Conduct inspection of incoming raw materials, first article parts, in-process materials, and finished goods Inspect both works in progress and completed tasks for compliance in accordance with the Purchase Order Instructions, Design Drawings and/or a Quality Control Plan, Safety, and contract requirements Help perform periodic stock inventories and prepare material requisitions for replacement items as required Perform other quality-related tasks as assigned by the Quality Manager Requirements 6+ years of experience working in a similar role Experience in Quality Control/Assurance Must be able to read and interpret schematics, blueprints, specifications, etc per ASME Y 14.5 and ASME Y 14.100 Experience using basic mechanical/electrical inspection/test tools (calipers, micrometers, multi-meters, surface plate, height gauges, comparator, gauge blocks, thread gauges, etc.) Experience working in an ISO 9001/AS9100 QMS environment Conduct 1st article inspections per AS9102 Experience in aerospace electro/mechanical quality control inspection Experience working with FAA Part 21 requirements performing and presenting parts to a DMIR or DAR for purposes of FAA Conformity Inspection Previous experience working with an ERP or MRP Proficient computer skills (MS Word, Excel, Outlook) Must have a clear understanding of document types that are impacted by Configuration Control Changes; e.g. Drawings & Specifications, Procedures and Work Instructions Ability to use a computer for inputting and storing data in specific folders Benefits The starting pay range for this position is $19.00 /hour to $28.25 /per hour however, base pay offered may vary depending on skills, experience, job-related knowledge and location.