Process Development Engineer

Process Development Engineer Status: Full-time, Exempt Reports to: Sr. Director of R&D Location: Onsite Santa Clara, CA About the Role VahatiCor, a T45 Labs portfolio company, is seeking a hands-on Process Development Engineer with strong catheter device experience, deep process development expertise, and a track record of building scalable, compliant manufacturing processes. The engineer will collaborate closely with R&D, Quality, and Manufacturing to establish robust processes, equipment, and documentation in a fast-paced, startup environment. Key Responsibilities  ·       Oversee supplier performance and relationships to guarantee consistent delivery of high-quality components, materials, and finished goods. ·       Develop and qualify test procedures to assess critical quality attributes and product specifications. ·       Design and implement fixtures and methodologies for product testing and manufacturing processes. ·       Author and execute comprehensive engineering protocols and reports to support phases of Design Verification and Process Validation. ·       Author and maintain process documentation (MPIs, SOPs, work instructions, test methods, protocols, and validation reports). ·       Partner with R&D and Quality to ensure all processes meet FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements. ·       Lead transfer of catheter manufacturing processes from external contract manufacturers to internal operations. ·       Plan and execute process characterization, DOE, and capability studies to ensure consistency and scalability. ·       Develop, optimize, and validate manufacturing processes, including equipment, tooling, and fixtures. ·       Perform/support root cause analysis and corrective actions (CAPA) to address manufacturing issues and supplier corrective actions (SCARs) to address issues at the supplier. Qualifications ·       Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline. ·       3-5 years of hands-on process development experience in the regulated medical device industry (catheter or interventional device strongly preferred). ·       Demonstrated success in process transfer, scale-up, and validation. ·       Experience with catheter assembly, bonding, molding, extrusion, and testing methods. ·       Strong knowledge of FDA QSR, ISO 13485, and risk management standards. ·       Proficiency in equipment qualification (IQ/OQ/PQ), DOE, and statistical analysis tools. ·       Strong documentation and communication skills; able to thrive in a dynamic startup environment. ·       Hands-on, proactive problem-solver with startup mentality. Eligibility Candidates must be legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas. Location & Compensation This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. There is no relocation package available. T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package. The anticipated salary range of this position is $115,000 - $155,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. Equal Employment Opportunity Statement T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. Third-Party Recruiter Notice We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email careers@t45labs.com.