Senior Process Development Engineer

Primary Duties And Responsibilities

• Develop and optimize manufacturing processes for medical devices, with focus on performance, quality, scalability, and efficiency.
• Led process characterization activities and transition processes through OQ readiness and commercialization.
• Drive continuous improvement initiatives to enhance product quality, reduce manufacturing cost, and increase manufacturing throughput.
• Apply structured problem-solving methodologies such as 5 Whys, Fishbone, and statistical analysis to resolve process issues.
• Lead risk management activities in accordance with ISO 14971 and FDA 21 CFR Part 820, including hazard analysis, failure mode assessment, and risk mitigation throughout the product lifecycle.
• Partner with cross-functional teams including R&D, Quality, and Manufacturing to ensure seamless integration of new processes into production environments.
• Conduct feasibility studies and pilot programs to evaluate and implement new process technologies and manufacturing methods.
• Support development and optimization of processes related to catheter or sheath manufacturing, including assembly, adhesive joining, thermal bonding, and reflow processing.
• Implement mistake-proofing strategies (poka-yoke) and automation approaches to improve assembly reliability and reduce human error.
• Drive mechanization and automation initiatives to improve process consistency, throughput, and manufacturability of catheter-based devices.
• Design and implement automation solutions and jig fixtures to streamline manufacturing processes and reduce manual intervention.
• Oversee implementation of automated processes ensuring compliance with safety standards and regulatory requirements.
• Lead validation activities including IMV, TMV, IQ, OQ, and PPQ, including protocol development, execution, data analysis, and report generation.
• Develop robust validation strategies and technical documentation aligned with regulatory expectations.
• Create and maintain documentation including SOPs, work instructions, validation reports, and process flow documentation in accordance with GMP requirements.
• Ensure manufacturing processes comply with Good Manufacturing Practices (GMP) and applicable global regulatory requirements.
• Partner with Quality Assurance to address compliance issues and implement corrective and preventive actions.
• Maintain strong adherence to ISO 13485 quality system requirements and related documentation practices.
• Provide manufacturing input during product development, ensuring design decisions support manufacturability and scalability.
• Collaborate with Manufacturing to support technology transfer and process scale-up into production.
• Lead cross-functional technical discussions and coordinate with external manufacturers or test facilities when needed to advance company technologies.

Skills, Knowledge, Experience & Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related scientific field; advanced degree preferred.
• 5+ years of experience in Process Development and Validation within the medical device industry, preferably with Class III medical devices.
• Demonstrated expertise in catheter or sheath manufacturing processes, including assembly, adhesive joining, thermal bonding, and reflow processing.
• Strong experience in process characterization and transition to OQ, including assembly mistake-proofing and root cause resolution.
• Proven track record executing validation activities (IQ, IMV/TMV, OQ, PQ) including protocol creation, execution, and report writing.
• Experience preparing technical reports, validation reports, and engineering studies in a regulated environment.
• Experience with cleaning validation development and execution is highly beneficial.
• Familiarity with automation techniques and jig fixture design in manufacturing environments.
• Experience working with biological materials or tissue-based medical device products is highly desirable.
• Strong knowledge of GMP, ISO 13485, FDA Quality System Regulations, and validation documentation practices.
• Excellent analytical, troubleshooting, and problem-solving abilities.
• Strong communication skills and the ability to collaborate effectively across cross-functional teams.

Compensation

Target base salary range: $120,000 – $135,000, plus eligibility for an annual short-term incentive (STI) targeted at 8.5% of base salary and equity participation. Final compensation will be determined 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.
• Inclusive Team Environment - 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.

Note

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