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Senior or Staff Manufacturing Engineer
4 weeks ago
START-UP COMPANY INFO:
- Well-Funded Class III Cardiovascular medical device startup, 35 people
- Location: Menlo Park, CA
- Flagship device is a Catheter-based device with novel technology for vascular access and stabilization in-situ.
- Device Status: FIH soon; with IDE Trial starting later this fall.
- 35MM Round B Funding in place from Strategic & VC Investors.
- Position will report to a VP.
POSITION SUMMARY:
The Senior Manufacturing Engineer will focus on development of our product in a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful equipment, fixture, and process design, as well as experience with manufacturing transfer. 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 platform.
ROLES AND RESPONSIBILITIES
- Procure and install off the shelf manufacturing equipment and fixturing and perform qualification activities as required.
- Lead transfer of manufacturing line to a new facility.
- Define, design, document and/or specify manufacturing assembly fixtures and equipment and develop/perform IQ/OQ/PQ on equipment and fixtures.
- Maintain equipment and fixtures on the line to prevent line down situations
- Collaborate with product development and NPI team to fully understand the product, process, quality control plans, etc. and ensure the highest quality products are manufactured.
- Author and maintain manufacturing documentation, including protocols, reports, manufacturing process instructions (MPIs), lot history records (LHRs), work instructions (WIs), test methods (TMs) and, if required component/product drawings.
- Define and implement continuous process improvements to existing manufacturing operations including process verification, manufacturing documentation updates and process validation, etc. to improve scalability, product reliability, and cost structure.
- Upgrade our manufacturing processes to ensure proper DFM and maximum scalability of our medical devices.
- Work with a cross functional team to address product issues in the field.
- Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
- Support the assembly line for our design verification & validation and clinical launches.
- Identify new potential vendors and suppliers and maintain relationships with existing vendors and suppliers.
- Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure GMP.
- Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic.
- Lead quality system compliance including discrepant material dispositions, ECO implementation, and nonconforming evaluations.
- Provide leadership and mentorship to team members as needed.
- Other responsibilities to support sustaining manufacturing deliverables as needed.
REQUIRED QUALIFICATIONS
- B.S. or M.S. in Mechanical or Related Engineering
- 6+ years of work experience in a MEDICAL DEVICE company
- Demonstrated experience working with cross functional teams.
- Generated and managed manufacturing documentation for a commercial medical device product (MPIs, LHRs, BOMs, TMs, flowcharts, etc.)
- Capable with CAD modeling, engineering drawing generation, DFM, tolerance analysis and tooling design
- Possess knowledge of process validation, GMP, and state-of-the-art manufacturing processes
- A driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company
- Experience working on design controls and equipment/fixturing qualifications, including IQ/OQ/PQ
PREFERRED QUALIFICATIONS
- Experience with disposables/consumables
- Experience with development of catheters
- Experience in a start-up environment
- Proficient with SolidWorks
- Experience working with contract manufacturers
- Experience working with 3D printers
- Experience creating and managing schedules, budgets, and plans
- Experience with packaging and shipping validations
Local Candidates strongly preferred
NO HIB CANDIDATES OR SPONSORSHIPS
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