Senior Process Development Engineer

Primary Duties and Responsibilities

• Plan and execute development and optimization of manufacturing processes for Class III transcatheter heart valves.
• Drive process characterization, improvements, and capability studies to establish robust and commercial-ready valve manufacturing processes.
• Provide DFM/DFA input during product development to ensure manufacturability and cost efficiency.
• Support global manufacturing alignment as processes are standardized and scaled.
• Author and execute validation strategies, including IQ, OQ, PQ/PPQ, TMV, IMV and equipment qualifications in alignment with the Master Validation Plan and applicable regulatory requirements (FDA, ISO 13485, and EU MDR).
• Ensure robustness of the validation packages meeting industry requirements for auditability and regulatory compliance. are audit-ready and inspection-ready.
• Partner with R&D, Quality and Regulatory during process developments, regulatory submissions and periodic inspections.
• Support risk management activities including PFMEA and control plan development.
• Evaluate and implement emerging technologies for semi-automated and automated solutions for fixture design, assembly processes, and test methods, including establishing equipment specification, and vendor selection.
• Improve repeatability and reduce operator variability through fixture optimization and automation strategies.
• Evaluate and implement bioburden solutions for valve manufacturing, ensuring effectiveness and process compatibility.
• Improve and establish visual inspection methods for tissue and valve manufacturing, ensuring repeatability and reproducibility.
• Plan and execute product performance and functional assessments associated with process changes and improvements.
• Drive design transfer activities from R&D to Manufacturing.
• Develop manufacturing documentation including SOPs, work instructions, process flows, and training materials.
• Provide on-floor technical support for complex builds, process deviations, and yield improvements.
• Investigate nonconformances and drive root cause analysis and CAPA execution.
• Identify opportunities to improve yield, reduce scraps, and enhance cycle time.
• Lead structured problem-solving initiatives using data-driven methodologies.
• Support cost-of-goods reduction initiatives while maintaining compliance and product performance.

Skills, Knowledge, Experience & Qualifications

• Required Qualifications:
• Bachelor’s degree in Mechanical, Biomedical, Industrial, or related Engineering discipline with 5+ years of experience in Process Development or Manufacturing Engineering within Class III medical devices. 3+ years’ experience with a graduate degree.
• Demonstrated experience executing IQ/OQ/PQ/PPQ and Test/ Inspection Method Validation in a regulated environment.
• Experience with design transfer from development into regulated production.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and EU MDR expectations.
• Hands-on experience with fixture design, process automation, and equipment qualification.
• Proven ability to lead cross-functional initiatives and influence without direct authority.
• Proficient in technical documentation and verbal communication.
• Able to use microscopes and other magnification equipment.
• Preferred Qualifications:
• Degrees in Engineering or Chemical Engineering and/or an advanced degree (MS) in Engineering or related field desired.
• Direct experience with catheter-based or structural heart devices strongly preferred.
• Experience with transcatheter heart valves (TAVR, TMVR, TPV) or delivery systems.
• Experience working in a pre-commercial or scaling organization.
• Background in Class III medical devices.
• Knowledge of ISO 5840-1/ -3.

Compensation

• Target base salary range: $118,000 – $138,000, plus annual incentive opportunity and equity eligibility. Final compensation will be based on experience and alignment with role requirements.

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.
• Health and Wellness Offerings:
• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment

Note

• We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.