Validation Engineer

Sturtevant, WI 53177

Employment Type: Contract Job Category: Validation Job Number: 42510657 Compensation: $55-65 / hour

Job Description

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 Employee 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.

Meet Your Recruiter

Herman Davis
Technical Recruiter

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About Sturtevant, WI

Ready to take the next step in your career? Explore job opportunities in the vibrant area around Sturtevant, Wisconsin! Nestled in Racine County, this charming town offers a unique blend of small-town charm and big-city amenities, making it an ideal location for job seekers looking to grow and thrive. From the charming boutiques and art galleries in nearby Racine to the stunning Lake Michigan shoreline, there's no shortage of enchanting features to discover. Enjoy sampling the famous Wisconsin cheese at local eateries or catching a show at the Racine Theatre Guild. With easy access to Milwaukee just 25 miles north, where you can cheer on the Brewers or Bucks, Sturtevant provides a perfect balance of work and play. Don't miss out on the opportunity to kickstart your career in this picturesque and welcoming community. Explore our job listings today and take the first step towards a brighter future!