Process Development Engineer II

About the role

We are seeking a Process Development Engineer II to lead design and development activities across the full lifecycle of medical device products. You will work closely with project managers, customers, and internal teams to ensure timely delivery of high‑quality solutions.

Key responsibilities

• Create technical execution plans and deliverables in partnership with project managers.
• Lead design and development tasks, ensuring milestones are met and customer requirements are satisfied.
• Interact directly with customers to tailor technical deliverables to their needs.
• Generate concepts, solve technical problems, and mentor junior engineers and technicians.
• Oversee documentation for requirements, design output, verification, and testing in compliance with Heraeus and customer QMS.
• Make technical decisions on vendor selection, critical‑to‑quality items, and concept choices.
• Supervise team members, handling selection, training, performance management, and compliance activities.

Required profile

• Bachelor’s degree in Engineering (Mechanical preferred); Master’s degree is a plus.
• 5+ years of experience in the medical device industry and at least 8 years of overall engineering experience.
• Strong knowledge of product development, testing, modeling, and process validation.
• Familiarity with ISO 13485 design control and process validation documentation.

Required skills

• SolidWorks
• Six Sigma Green Belt or Black Belt
• ISO 13485

What we offer

• Opportunity to lead high‑impact medical device projects.
• Collaborative environment with mentorship responsibilities.
• Competitive compensation and benefits package.