Director of Process Development

Director of Process Development to lead the development, optimization, and scale-up of manufacturing processes for advanced catheter-based and electromechanical medical devices. This role will provide strategic and hands-on leadership across cross-functional teams to ensure robust, compliant, and cost-effective processes from early development through commercialization.

The ideal candidate brings deep technical expertise in medical device process development, strong people leadership, and a proven track record of driving manufacturing readiness in regulated environments.

Key Responsibilities

· Provide strategic and operational leadership for process development activities supporting catheter-based and electromechanical devices

· Lead, mentor, and develop a high-performing team of engineers and technical professionals

· Drive process development from concept through pilot, validation, and commercial scale manufacturing

· Partner closely with R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure seamless product transfer

· Establish and improve process development methodologies, tools, and best practices

· Oversee design for manufacturability (DFM), design for assembly (DFA), and process risk management (FMEA)

· Ensure compliance with FDA, ISO 13485, and applicable global regulatory requirements

· Lead process characterization, validation (IQ/OQ/PQ), and continuous improvement initiatives

· Manage budgets, timelines, and resource allocation to meet business objectives

· Support supplier development, qualification, and technology transfer as needed

Requirements:
· Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, Manufacturing, or related discipline)

· 10+ years of progressive leadership experience in process development or manufacturing engineering within the medical device industry

· Demonstrated experience with catheter technologies and/or electromechanical medical devices

· Strong knowledge of medical device regulations, quality systems, and manufacturing validation requirements

· Proven ability to lead cross-functional teams and influence at senior leadership levels

· Experience scaling processes from development to high-volume manufacturing

· Excellent communication, problem-solving, and decision-making skills.

Preferred Qualifications

· Master’s degree in Engineering, Science, or Business

· Experience supporting global manufacturing operations

· Background in automation, precision assembly, or high-volume disposable and reusable device manufacturing

· Lean Manufacturing, Six Sigma, or similar continuous improvement certification.

Benefits:
Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• Employer subsidized health insurance and dental insurance for employees
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Salary Range for This Position: $150,000 - $240,000

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.