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$92,000-124,000/year
T45 Labs
Santa Clara, CA, USA
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ShareVahatiCor, a T45 Labs portfolio company, is seeking an Engineering Project Manager with a strong background in Mechanical or Biomedical Engineering to lead the development and manufacturing of Class II and Class III medical devices, with a focus on catheter systems. The successful candidate will oversee cross-functional project execution from concept through commercialization, coordinating closely with R&D, Quality, Regulatory, Clinical, and Manufacturing functions. This role is ideal for someone who thrives in a startup environment and is motivated to help bring novel therapies to patients. Responsibilities Project Management & Leadership Drive end-to-end execution of product development programs, ensuring adherence to scope, schedule, budget, and quality. Develop and maintain detailed project timelines, resource plans, and milestone tracking tools to ensure cross-functional alignment. Serve as the primary point of contact between internal teams and external design and manufacturing partners, including contract engineering firms. Lead regular team meetings, project status reviews, and design reviews to facilitate decision-making and maintain momentum. Proactively identify and manage risks, implement mitigation strategies, and communicate issues and solutions to stakeholders and leadership. Cross-Functional Coordination Collaborate with cross-functional stakeholders including Regulatory Affairs, Quality Assurance, Clinical Affairs, and Operations to ensure technical deliverables meet all internal requirements and external regulations. Partner with supply chain and external manufacturers to define manufacturing processes, transfer designs to production, and scale up operations. Support Design Control activities in accordance with ISO 13485 and FDA QSR requirements, including documentation and traceability throughout the product lifecycle. Documentation and Risk Management Create and manage technical documentation including Manufacturing Process Instructions (MPIs), assembly and test procedures, design verification protocols, and test reports. Lead risk management activities such as Failure Modes and Effects Analysis (FMEA) and hazard analysis in compliance with ISO 14971. Ensure design outputs align with product requirements, clinical use cases, and regulatory expectations. Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related science field; Master’s degree a plus. 5+ years of experience in medical device R&D or engineering project management, with hands-on development experience in catheter-based technologies. Proficient in SolidWorks for mechanical design and drafting. Strong understanding of ISO 13485, FDA 21 CFR Part 820, and ISO 14971. Experience with verification and validation testing, including mechanical testing (e.g., tensile, torque, kink resistance). Skilled in writing protocols, reports, and manufacturing documentation. Excellent organizational, interpersonal, and communication skills. Location and Compensation This is an on-site position, based in our Santa Clara, CA office. 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 $92,000 - $124,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations. 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.
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Irvine, CA, USA