Senior or Staff Manufacturing Engineer

4 weeks ago

Menlo Park, United States Cambridge Executive Recruiters Inc. Full time

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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