What are the responsibilities and job description for the Staff/Senior Manufacturing Engineer position at Noah Medical?
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
#LI-Onsite
