Engineer – Process Development

Key Responsibilities

• Lead early-stage manufacturing strategy alongside product development to ensure scalability.
• Establish feasibility during concept and prototype phases by evaluating materials, risks, tolerances, and throughput.
• Utilize rapid prototyping methods (machining, laser processing, additive manufacturing, molding).
• Develop scalable processes that transition effectively from prototype to full production.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) initiatives.
• Troubleshoot manufacturing issues using structured problem-solving and data-driven analysis.
• Design and implement fixtures, tooling, and process aids to improve robustness.
• Execute process verification and validation activities (IQ/OQ/PQ).
• Drive continuous improvement in yield, throughput, efficiency, and cost optimization.
• Prepare and maintain process documentation (work instructions, routings, PFMEAs, control plans).
• Support production readiness by transferring processes to operations and training personnel.

Qualifications & Skills

• Education: Bachelor’s degree required; master’s preferred.
• Experience: 7–10+ years in contract medical device or regulated manufacturing environment. Expertise in metal processing (precision machining, hypotubes, laser processing). Familiarity with plastic injection molding and cleanroom assembly operations. Hands-on capability in tooling, fixturing, and precision assembly. Knowledge of Lean Manufacturing, DOE, and statistical methods. Understanding of FDA and ISO 13485 regulated manufacturing requirements.
• 7–10+ years in contract medical device or regulated manufacturing environment.
• Expertise in metal processing (precision machining, hypotubes, laser processing).
• Familiarity with plastic injection molding and cleanroom assembly operations.
• Hands-on capability in tooling, fixturing, and precision assembly.
• Knowledge of Lean Manufacturing, DOE, and statistical methods.
• Understanding of FDA and ISO 13485 regulated manufacturing requirements.

Core Competencies

Why Join Us