Staff/Senior Manufacturing Engineer

About The Team: The Staff/Senior Manufacturing Engineer is responsible for sustaining and identifying and implementing continuous process improvements with an emphasis on process validation. The position will be responsible for on-demand production line support, measure manufacturing driven metrics (cycle times, capacity, bottlenecks etc.), design, duplicate and/or deploy manufacturing fixtures and tooling, develop and train on manufacturing processes and perform equipment qualification and process validation activities. A Day In The Life Of Our Staff/Senior Manufacturing Engineer: Collaborate with cross-functional teams to transition from prototype to production, addressing any design for manufacturing or design for assembly challenges. Design, document, assemble, qualify and release custom and off the shelf manufacturing and testing tooling, fixtures and equipment. Create and release associated maintenance and calibration procedures. Author and execute manufacturing documentation, including protocols, reports, manufacturing process instructions, work instructions and equipment/fixture specifications. Be a leader in process validation (IQ/OQ/PQ/PPQ) for the team, developing the protocols and test processes. Create and revise manufacturing-related risk documents including pFMEA’s and Manufacturing Line Specifications. Provide daily support to troubleshoot and resolve manufacturing production issues including material, method, while following GMP and the company Quality Management System. Identify root cause(s) of operational failures and support Corrective and Preventive Action plans by providing solutions using problem-solving skills including Fishbone, 5 Whys, Pareto Charts etc. Generate production metrics including yields, scrap rates, capacity/bottlenecks and cycle times and routinely present to management. Define and implement continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation. Other manufacturing engineering duties or support as assigned or requested. This role requires the use of varying levels of personal protective equipment (including, gowns, masks/face shields, gloves, and safety glasses). About You: Degree in Manufacturing/Industrial, Mechanical, or Electrical Engineering. Minimum 5 years experience in the medical device industry in a manufacturing engineering capacity working with complex hardware/software devices. Catheter experience is a plus! Experience in working with CM, especially an OUS CM. Working knowledge of ISO 13485 and 21 CFR 820. Understanding of statistical methods. SolidWorks or equivalent experience. Proficient with standard business software (MS Office, Excel, Outlook etc.). Excellent written and oral communication skills are required. Workplace Type:

Onsite Benefits & Perks (For Full Time Employees): Competitive Salary. Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options. Equity & Bonus Program. Life Insurance (company paid & supplemental) and Disability insurance. Mental health support through medical insurance programs. Legal and Pet Insurance. 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days. Paid parental leave. In-office snacks and beverages. In-office lunch stipend. Learning & Development Opportunities: On-demand online training and book reimbursement. Team building and company organized social and celebration events.

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