Process Development Engineer - Enfield, CT
Branch ID: 5246
Pay Rate/Salary: $70,000.00 - $100,000.00
Medical Device Process Development Engineer
Intermediate and Senior Process Development Engineer opportunities in Medical Device Manufacturing for a local candidate in the Enfield, CT area!
The Process Development Engineer works in a project engineering group consisting of multiple engineering disciplines involved in the design, development, documentation and validation of new medical device products, and modification of existing medical device products.
Scope of work includes defining requirements, timelines and deliverables with a focus on prototypes, process development, life cycle knowledge, qualifications, design verification, clinical builds, training production and preparation for process validation and manufacturing transfer of products to commercialization.
Responsible for the following Medical Device project inputs:
Feasibility builds, documentation and testing
Process development and documentation
Device Verification samples and testing
Process Failure Mode Effects Analysis
Involvement in the full design, development and validation requirements of projects:
Product design and specification creation, including mechanical and electrical components, BOMs, assemblies and packaging
Materials sourcing and device prototyping
Design verification and validation activities, including data for regulatory submission
Arranges and attends project meetings to discuss current and future design and development initiatives.
Assists with the preparation of proposals and quotations for clients and interfaces to resolve questions in a timely manner.
Assists in preparation and maintaining project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions.
Tracks and communicate project status, plans, issues, timelines, action items, and budgets.
Provides guidance and direction on areas of technical expertise.
Troubleshoots production processes.
Evaluates and selects test methods for product requirements
Experience in a highly regulated industry and 5+ years of experience in Process Development defining requirements, timelines, design verification, product builds and transfer to commercialization.
The Company supports affirmative action and equal employment opportunity. The Company will provide equal employment in employment practices to all applicants for employment. Employment decisions shall be made without regard to any protected characteristic such as, but not limited to, race, color, religion, gender, age, disability, national origin, ancestry, citizen status, gender identity, sexual orientation, marital status, status in regard to public assistance, disabled veterans, recently separated veterans, Armed Forces service medal veterans and other protected veterans, genetic information and other legally protected classes. Furthermore, the Company is an E-Verify employer. Information provided on this application will not be used for any discriminatory purposes. The Company complies with all applicable federal, state and local non-discrimination laws and regulations. The Company will provide reasonable accommodations in the application or interviewing process. If you need a reasonable accommodation in the application or interviewing process, please contact us.
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Process Development Engineer
City, State or Zip Code: Enfield, CT
Position Type: Direct Hire Position
Date Posted: 12/26/2018