The Sr. Process Engineer position available through IntePros in Jacksonville, FL is an exciting opportunity for candidates with experience in medical device manufacturing. This role primarily involves supporting the manufacturing of minimally invasive laser ablation systems used in MRI-guided treatments for brain tumors, epilepsy, and radiation necrosis. The job focuses on improving production efficiencies, quality standards, and manufacturing techniques for existing products.
Job Responsibilities:
- Integration of Equipment & Materials: Ensure equipment and materials align with target specifications for manufacturing processes.
- Collaboration with Design Teams: Work with product design teams to ensure process compatibility and provide feedback on design specifications.
- Process Innovation & Optimization: Lead the development of new manufacturing processes, including material selection, equipment and tooling decisions, and process validation.
- Statistical Process Control (SPC): Implement and develop SPC techniques to improve manufacturing processes and outputs.
- Process Validation & Design Transfer: Lead process validation activities and ensure seamless transfer of designs into production.
- Supplier Quality Management: Ensure suppliers meet quality standards, monitor performance, and address quality issues collaboratively.
- Regulatory & Compliance: Ensure all manufacturing processes comply with relevant regulatory standards (e.g., FDA, ISO).
- Collaboration Across Teams: Work closely with NPI teams, quality control, and supply chain to ensure efficient manufacturing processes and optimal project outcomes.
Required Qualifications:
- Education: A Baccalaureate degree (or equivalent experience) in Engineering or a related field. A master's degree with 2+ years of experience is also acceptable, or a bachelor's with 4+ years of experience.
- Industry Experience: At least 2 years in the medical device industry, with experience in Design for Manufacturability, Design Transfer, and Process Validation.
- Statistical & Process Engineering: Experience with statistical methods (e.g., Design of Experiments) and process characterization.
- Experience with Contract Manufacturers: Must have worked with contract manufacturers and suppliers to ensure product quality and timely delivery.
- Additional Skills: Experience with automation, fixturing, and new process development is a plus.
- Certifications: Design for Reliability & Manufacturability (DRM) certification is desirable, though not required.
Position Details:
- Contract: 1-year contract with possible extensions.
- Location: 100% on-site in Jacksonville, FL.
- W2 Employment: This is a W2 position, open to U.S. Citizens and Green Card holders.
If you are interested in this Sr. Process Engineer position, you can apply via IntePros’ website or contact Robert Schemel at rschemel@intepros.com for more details.
