Senior or Staff Manufacturing NPI Engineer - Catheters

Cambridge Recruiters; Burlingame (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative medical device company is seeking a Senior or Staff Manufacturing NPI Engineer to lead the development of cutting-edge catheter manufacturing processes. This exciting role involves collaborating with cross-functional teams to enhance product development, reduce costs, and implement advanced manufacturing techniques. The ideal candidate will have a strong background in medical device engineering, particularly with catheter-based devices, and will thrive in a fast-paced, start-up environment. If you are passionate about making a significant impact in the medical field and possess the skills to drive manufacturing excellence, this is the perfect opportunity for you.

Qualifications

• 5+ years of experience in medical device engineering, especially with catheters.
• Proven success in developing catheter manufacturing processes.

Responsibilities

• Design and prototype manufacturing processes and equipment for catheters.
• Manage the flow of WIP through Lean practices including Kanban and 5S.

Skills

Catheter Manufacturing Processes

Cross-Functional Team Collaboration

CAD Modeling

Process Validation

GMP Knowledge

Design Controls

Engineering Drawing Generation

Education

B.S. or M.S. in Mechanical Engineering

Related Engineering Degree

Tools

SolidWorks

3-D Printers

Lathe

Drill Press

Band Saw

Job description

Senior or Staff Manufacturing NPI Engineer - Catheters

POSITION SUMMARY:

The Senior/Staff NPI Manufacturing Engineer will focus on further developing our product and then transferring it into a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful process, tooling and equipment design.

This role will engage in cross-functional collaboration to accelerate the product development process, reduce cost of goods, and enable more complex designs through manufacturing improvements.

The ideal candidate will act with passion and intensity in a medical device start-up that is fast-paced and collaborative and will display the ability to perform to the requirements outlined below.

For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES

1. Work with product development to design and prototype novel manufacturing processes and equipment
2. Design and prototype novel manufacturing equipment and fixturing
3. Create and maintain necessary Manufacturing Process Instructions (MPI’s), test methods, product drawings, and component specifications
4. Upgrade our manufacturing processes to ensure proper DFM and maximum scalability of our medical devices
5. Initiate and implement programs to continuously improve quality, cost, and cycle time
6. Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
7. Provide technical support and perform failure analysis for non-conforming components, assemblies, and process defects
8. Build the assembly line for our clinical launches
9. Specify, support, and maintain the proper CER space to manufacture our medical devices under defined environmental quality controls.
10. Manage the flow of WIP through Lean practices including Kanban and 5S.
11. Maintain relationships with key vendors and suppliers and support supplier validations
12. Emphasize quality and utilize a risk-driven approach to ensure compliance with risk management policies and practices and ensure GMP.

REQUIRED QUALIFICATIONS

1. B.S. or M.S. in Mechanical or Related Engineering
2. 5+ years of work experience with a Medical Device Company
3. 3-5+ years working on Catheter-Based devices, catheters, delivery systems.
4. MUST HAVE: Demonstrated success developing catheter manufacturing processes including braiding, coil winding, extruding, lamination, adhesive joining, die bonding, and laser welding.
5. Demonstrated experience working with cross-functional teams.
6. Proven track record of generating and managing manufacturing documentation from concept to commercialization for medical device products (MPIs, LHRs, BOM, flowcharts, etc.)
7. Capable with CAD modeling, engineering drawing generation, DFM, tolerance analysis, and tooling design
8. Possess knowledge of process validation, GMP, and state-of-the-art manufacturing processes
9. A driven outlook with a strong desire to succeed as an engineer, as a team, and as a company.
10. Solid understanding of design controls

PREFERRED QUALIFICATIONS

1. Experience with disposables/consumables
2. Experience managing lab technicians and assemblers.
3. Developed products from invention to market release.
4. Experience in a start-up environment.
5. Proficient with SolidWorks.
6. Experience creating and managing schedules, budgets, and plans.
7. Experience with packaging and shipping validations

Office Location: Burlingame, CA, near the Millbrae Caltrain and BART station.

Will consider H1B Transfer or Green Card Sponsorship candidates - YES.

Local Candidates preferred, however will consider relocation for well-qualified candidates.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Manufacturing

Industries

Medical Equipment Manufacturing