Sr. Manufacturing Engineer
4 weeks ago
The 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 Senior Manufacturing Engineer:
Be a leader in process validation (IQ/OQ/PQ/PPQ) for the team, developing the protocols and test processes
Provide daily support to troubleshoot and resolve manufacturing production issues including material, method, while following GMP and the company Quality Management System.
Create and revise manufacturing-related risk documents including pFMEA’s and Manufacturing Line Specifications
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.
Perform routine equipment preventative maintenance and/or repair and serve as manufacturing liaison for external calibration activities.
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.
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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