Sr Process Development Engineer
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Sr Process Development Engineer
Title:Sr Process Development Engineer
The DAVIS Companies has partnered with a global leader in the medical device industry by securing a Sr Process Development Engineer. Please review the below description and if interested in this role, please apply with your Word formatted resume with contact information to be reached. You may also follow up with Rich Gardner, Talent Acquisition Manager with your resume at email@example.com.
A high performing individual that will drive the development of medical device manufacturing processes from prototype assembly to production manufacturing. The desired individual will possess a broad range of medical device design and development skills and experience, as well as depth of knowledge of process development, process validation, lean manufacturing methodology, and statistical process control.
Essential Job Duties and Responsibilities
• Develop and document manufacturing processes for medical devices (disposable and reusable), catheters, implants, and/or packaging, from concept through market introduction.
• Drive process design and product design for manufacturability (DFM) to ensure robust and capable manufacturing processes.
• Plan and execute assembly, documentation and qualification of manufacturing line.
• Plan and execute process characterization studies to determine optimal process windows.
• Develop in-process inspections to ensure conformance to product requirements.
• Design and procure process equipment, tooling, fixtures, and assembly aids.
• Implement process improvements and controls to reduce assembly time and drive yield improvements.
• Conduct process risk analysis (PFMEA) for products under development and implement process controls to drive risk mitigations.
• Plan and execute process validations including IQ, OQ, PQ and PPQ activities.
• Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
• Any other duties as assigned.
Education and Experience
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Ma
• Minimum of 10 years of medical device product and process development experience is required. Catheter, reinforced catheter, balloon catheter experience a plus.
Skills and Abilities
• Demonstrated ability to bring products from concept to market.
• SolidWorks 3D CAD proficiency.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• Knowledge of probability and statistics.
• Depth of knowledge in one or more clinical areas; interventional cardiology is desired.
• Depth of knowledge in one or more product areas; catheters is desired.
- Warehouse Associate in Milford MA
- Embedded Engineer in Ashland MA
- AP Clerk in Hopedale MA
- Production Assistant in Brooklyn Park MN
- Maintenance Multi-Craft Day Shift in Gainesville GA
- Maintenance Technician in Lawrenceville GA
- Electrical Engineer in Littleton MA
- Material Handler in Suwanee GA
- Project Engineer in Sterling MA
- Manufacturing Engineer in Sterling MA
- Customer Service Rep in Needham Heights MA
- Receptionist in Alpharetta GA
- Field Service Engineer in Columbia MD
- Outside Account Manager in Brooklyn Park MN
- NDT Level III Inspector in Santa Fe Springs CA
- NDT Level II Inspector in Santa Fe Springs CA
- Mechanical Design Engineer in Gainesville GA
- Quality Control Inspector in Cumming GA
- Assembler - Kitter in Milford MA
- Mechanical Drafter in Brooklyn Park MN
- QC Inspector in Bedford MA
- Solidworks Drafter in McBee SC
- IT Recruiter MA in Woburn MA
- Electrical Engineer in Alpharetta GA
- Material Handler in Lindon UT
- Manufacturing Engineer in Pendergrass GA
- Customer Care Coordinator in Suwanee GA
- 2nd Shift Machine Operator in Newton MA
- Facilities Technician in Ashland MA
- Collections Specialist in Norwell MA
- Financial Analyst in Milford MA
- Inventory Controller in Lebanon NH
- Shipper in Plymouth MA
- Sr. Assembly Technician in East Boston MA
- CAD designer in Hudson MA
- Welder in Duluth GA
- Safety Engineer in Norcross GA
- Material Handler in Taunton MA
- Manufacturing Supply Chain Clerk in Doraville GA
- Shipping in Duluth GA
- Mechanical Packaging Engineer in Ayer MA
- Manufacturing Lab Technician in Norwood MA
- Maintenance Planner in Gainesville GA
- Engineering Intern in Memphis TN
- Order Processor in Duluth GA
- Planner in Duluth GA
- Depot Repair Technician in Duluth GA
- Receiving Material Handler in Flowery Branch GA
- Warehouse in Suwanee GA
- Deployment Team in Suwanee GA
- Assembler in Acton MA
- Technical Recruiter MA in Marlborough MA
- QA Technician in Lawrence MA
- ID-OD GRIND MACHINIST in Santa Fe Springs CA
- Mechanical Engineer in Marlborough MA
- Controls Engineer in Vance AL
- Electrical Design Engineer in Suwanee GA
- Wiring Technician in Suwanee GA
- Mechanical Design Engineer in Suwanee GA
- HR Director in MA
- CNC Machinist in Contoocook NH
- Sr. Electrical Designer in Alpharetta GA
- Quality Engineer in Minneapolis MN
- 2nd Shift Machine Operator in Plymouth MA
- Shipper- Warehouse Associate (seasonal) in Ashland MA
- Control Panel Power Wirer in Brooklyn Park MN
- Maintenance Controls Tech in Gainesville GA
- Electro-Mechanical Assembler - Technician in New Brighton MN
- Buyer in Milford NH
- Shipping Clerk in Brooklyn Park MN
- Bench Repair Technician in Cumming GA
- Welder - Sheet metal fabricator in N. Billerica MA
- Program Manager in Saint Petersburg FL
- electro-mechanical assemblers in Merrimack NH
- Standard Fabrication - 1st Shift in Suwanee GA
- Quality Engineer in Newnan GA
- Firmware Engineer in Framingham MA
- Maintenance Mechanic in Lynn MA
- EM Assembler in Westborough MA
- Manufacturing Engineer in Lowell MA
- Quality Engineer in Maple Grove MN
- Packaging Supervisor in Lynn MA
- Technical Writer in Norwell MA
- Accountant in Loganville GA
- Assembly in Buford GA
- Wiring Technician in Buford GA
- Production Admin in Duluth GA
- Shift Supervisor in Duluth GA
- Maintenance Mechanic, Class A, 1st shift in Worcester MA
- Industrial Engineer in Loganville GA
- 2nd Shift Shipping Lead in Lynn MA
- Quality Engineer in Clinton MA
- Quality Manager in Dover NH
- Assembly Technician in Tucker GA
- Assembler in Suwanee GA
- Press Brake Operator in Duluth GA
- Mechanical Engineer in Bedford MA
- Process Engineer in Covington GA
- Refrigeration Technician in Acton MA
- Electrical Technician in Milford MA