Process Engineer - Cumberland, Ri - Medical Device

• This is an exciting opportunity for a highly technical junior-mid level engineer|This company offers amazing benefits, PTO, and a quick interview process!

About Our Client
This client is a leader in medical device contract manufacturing creating vital coating materials for lead medical device clients across the globe.

Specific responsibilities for the Process Engineer include but are not limited to:

• Test Execution and Data Collection
• Support Pilot/Production Line equipment and process status for new products processes
• Supports engineering initiatives and projects, as well as sustaining support of manufacturing operations
• Lead operations to increase production capacity and implement new efficient processes.
• Owning Process Validation: Coordinates validation activities with, and seeks team support from, Project Management, Manufacturing, Engineering, Quality, third Parties, etc.
• Support R&D Pilot/Production Line Support and Engineering
• Initiate, Review, and Approve Document Change Orders
• MFG ramp-up/scale up experience
• Initiate and lead lean manufacturing process improvement projects
• Own Design Transfer Phase Activities: Evaluate current catheter manufacturing practices and identify those needing improvement
• Communicating with cross-functional internal team as well as Vendors, Suppliers, and Contract MFGs for purchasing and getting supports, etc.
• Responsible for performing manufacturing processes validation and equipment validation. This includes developing preparing master validation plans, drafting protocols, analyzing test results, and drafting/routing technical reports

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
A successful candidate will have the following background:

• Product hands on experience in Medical Device (preferably Class II/III Med Devices e.g., Catheter/Balloon/etc.)
• Knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices
• Bachelor's Degree or Master's degree in Biomedical, Mechanical, or Industrial Engineering or a related Engineering field
• Familiarity with regulated environment
• Able to work in Cleanroom
• Need Medical Device Experience
• BS +6 years or MS +4 years of Manufacturing and Process Development experience (at least 4 years of it in relevant experience as job description in medical device industry)

What's on Offer
The Process Engineer will be offered:

• Benefits package that includes: health, dental, 401k, PTO and more
• Competitive base salary
• One of the fastest growing medical device products in the country
• Management Opportunity: ability to grow a team of engineers as the product develops
• HYBRID work schedule (Fridays work from home)

Contact: Madeleine Ammons
Quote job ref: JN-042023-6023386