Manufacturing Engineer - Disposables

About The Team:

The Manufacturing Engineer is responsible for sustaining and identifying and implementing continuous process improvements with an emphasis on sustaining. 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 [Insert Title >:

• 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.
• Draft and perform process validation (IQ/OQ/PQ/PPQ) for the team, developing the protocols and test processes
• 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 1 years experience in the 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 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