What are the responsibilities and job description for the Validation Engineer position at Sterling Engineering, Inc.?
Title : Biomedical Engineer
Location : Sturtevant , WI
Hire Type : CONTRACT
Payrate : 55-65 / HR
Overview :
Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
As a contract employee of Sterling, you are eligible to receive a Full Em ployee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Job Summary :
Biomedical Engineer – Medical Device Company
We are seeking a Biomedical Engineer with strong mechanical and electrical aptitude, a pragmatic problem-solver with an innovative mindset, and a hands-on approach to prototyping, testing, and device assembly. The ideal candidate should be comfortable working with everything from basic drawings to detailed 3D models and possess the skills to thrive in a collaborative, fast-paced environment.
Key Responsibilities
Documentation and Process Development
Create and manage assembly procedure documentation, including work instructions, drawings, and specifications, adhering to established Quality Management System (QMS) requirements.
Manufacturing Support
Apply manufacturing engineering and Design for Manufacturing and Assembly (DFMA) principles to optimize component manufacturing processes, tooling / equipment design, and material properties.
New Product Development
Support product development through prototype assembly, testing, and inspection of product components.
Design tools, fixtures, and equipment and generate associated documentation.
Collaborate with R&D to ensure designs are optimized for manufacturability and reliability.
Quality Improvements
Conduct and analyze Design of Experiments (DOE), correlation studies, and statistical analyses to drive process and product improvements.
Design Controls Compliance
Contribute to User Requirements and System Requirements documentation.
Ensure adherence to ISO13485 standards, FDA regulations, and Good Manufacturing Practices during product and process development.
Supplier Evaluation and Selection
Identify and evaluate potential suppliers to support manufacturing and development needs.
Qualifications
Education
Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, or related field – Required
Experience
0–2 years of design and manufacturing experience in the medical device or component industry – Required
Familiarity with Design Control processes, including design and process verification and validation
Experience with manufacturing and assembly process validation (IQ, OQ, PQ, PPQ)
Knowledge of injection molding and electronic assembly processes
Skills and Competencies
Proficiency in test method validation, GR&R, GD&T, and statistical analysis
SolidWorks or other CAD software experience
Practical knowledge of Six Sigma methodologies (Green or Black Belt certification preferred)
Familiarity with ISO Quality System requirements and FDA regulations
Strong understanding of mechanical and electromechanical manufacturing processes
Effective collaboration with internal and external teams
Ability to deliver results independently and support junior engineering staff
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.
Salary : $55 - $65
