Senior or Staff Manufacturing Process Engineer Senior or Staff Manufacturing Process Engineer Get AI-powered advice on this job and more exclusive features. This range is provided by Cambridge Recruiters. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $140,000.00/yr - $175,000.00/yr Additional compensation types Annual Bonus and Stock options Direct message the job poster from Cambridge Recruiters JOB TITLE: Senior or Staff Manufacturing Engineer (title flexible) COMPANY SUMMARY: Vascular Medical device start-up located in Menlo Park and led by a team of successful medical device entrepreneurs. Culture is built on innovation, teamwork, and speed. We have raised capital from a diversified investor base including venture capital, private equity, corporate strategic investors, and clinician angel investors. Round B currently. 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 manufacturing and a record of successful manufacturing line support, process validation and manufacturing line transfer. This role will engage in cross-functional collaboration to accelerate the product development process, reduce the 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 innovative medical pulmonary embolectomy platform. ROLES AND RESPONSIBILITIES Lead day to day manufacturing for our development and clinical products Plan and execute builds, trouble-shoot issues during execution including but not limited to material shortages, supply quality, equipment, process or facilities Lead development and implementation of facilities safety including hazardous waste disposal, and personnel safety 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. Work with a cross functional team to address product issues in the field. 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. Lead quality system compliance including discrepant material dispositions, ECO implementation, and nonconforming evaluations. Procure and install off the shelf manufacturing equipment and fixturing and perform qualification activities as required. Define, design, document and/or specify manufacturing assembly fixtures and equipment and develop/perform IQ/OQ/PQ on equipment and fixtures. 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. Lead material process flow and other CER bring-up related deliverables tied to transfer of manufacturing line to a new facility 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. Provide leadership and mentorship to team members as needed. Other responsibilities to support manufacturing deliverables as needed. REQUIRED QUALIFICATIONS B.S. or M.S. in Mechanical or Related Engineering discipline 5-8+ years of work experience in a medical device company Strong preference for experience with Catheters or other Min-Invasive devices 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 While not currently anticipated, this role may require occasional travel 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 Preferred, however some assistance may be given to well-qualified candidates from out of the area. Must Have US Work Authorization or be a US Citizen. (No H1B Transfers or Sponsorships) Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Manufacturing Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cambridge Recruiters by 2x Sign in to set job alerts for “Manufacturing Process Engineer” roles. 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