Salary Expectation: Based on the candidate's level of experience.
As an Engineer, Process Development, you'll play a pivotal role in developing, validating, and scaling manufacturing processes, collaborating with cross-functional teams to deliver practical, manufacturable, and compliant solutions in a fast-paced, customer-driven environment.
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.
Core Competencies:- Technical capability in process development.
- Validation, quality, and regulatory alignment.
- Problem-solving and continuous improvement.
- Cross-functional collaboration and communication.
- Execution discipline in documentation and prioritization.
Ready to make a difference? Apply today and be part of something extraordinary.
