Design and Validation Engineer (NPD) - Impact Business Group
Portage, MI
About the Job
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a New Product Developer Design and Validation Engineer for a 6 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
One Candidate will be support project Design of experiments OQ/PQ. Second Candidate will be responsible for development and validating the Process/Software/Applications for the production Equipment.
Top 3 must haves to perform the Job:
- Layout Experience
- Equipment Validation
- Minimum of 2 years; 3 or more preferred experience.
Position Description (Principle Duties and Responsibilities)
- Designs, validates and will bring new products to market.
- Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety.
- Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials.
- Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability.
- Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.
Requirements
- Bachelor's degree; in engineering or applicable technical field (mechanical or biomedical preferred) (M.S. or/and Ph.D. in Engineering or related field welcomed)
- 5+ years' of medical device design and development experience or electro-mechanical appliance or equipment
- Proven track record of collaborating with others to design and develop high priority medical technologies, preferred
- Supplier/Vendor Management will be a key function of the job will work very closely with external vendors procuring the parts and ensuring those parts meet specifications.
- Emphasis Process Validation..requires experience looking at and entire manufacturing assembly process and validating the whole process (pFMEA, Risk Analysis, Process Control Plans)
- Production Part Approval.
- Team player, quick learner, problem solver, self-motivated.
- Any experience working with Pressure Leak systems will be a huge asset
- Plastics Joining Welding experience will be preferred
- Excellence. Dedication. Passion.
Contract positions
Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.
Permanent placed employees
Paid by and qualify for benefits in accordance with the policies of the hiring company.
Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.
Internal Positions
We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.
- Recruiters
- Account Managers
Learn more about working with iMPact Business Group