Job description

Primary Location US-MI-Williamston
Other Locations US-MI-Howell
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*JOB SUMMARY:*
Design, develop, and launch unique and innovative products and related processes that provide positive outcomes for end users. Search and interpret intellectual property and develop designs that can be protected through patents, trademarks or other intellectual property techniques.
CORE JOB RESPONSIBILITIES:

• Develop design specifications, manage multiple project timelines, and balance corporate priorities for product development projects to ensure that deadlines and goals are met.
• Coordinate and support all phases of product development from ideation to 510k application to product launch and sustaining.
• Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, and cost saving opportunities.
• Direct activities related to product innovations and the manufacturing implications related to new product designs.
• With the assistance of Marketing, identifies, characterizes, and quantifies market opportunities for new products.
• Specify and design new material variants and product features, and incorporate into new product formulae.
• Direct qualification and testing activities required for regulatory clearance and to ensure product functionality over the life of the product.
• Work with vendors and internal QA to determine performance impact of new materials and designs, providing empirical data needed for marketing and manufacturing decision making. Provide guidance to QA team for corrective action on product failures. Implement corrective actions to QA challenges with vendors.
• Provide complete product design solutions to support the immediate, mid-term, and long-term innovation and product design strategies.
• Investigate and develop new manufacturing processes as necessary and oversee product/machine trials along with operations personnel to ensure manufacturability during product development and launch.
• Provides team and technical leadership in the execution of assigned projects, and meets commitments regarding product performance, cost, capacity and timing.

COVID-19 Vaccination
Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
BASIC QUALIFICATIONS:
Education

• Bachelor’s degree in Mechanical, Biomedical, Material Science, or Chemical Engineering or related discipline.

Relevant Work Experience

• At least 4 years of experience applying (Statistical Process Control) SPC, Design of Experiments (DOE) and/or Lean principles.
• Experience measuring, conducting testing functions, interpreting and performing test procedures, operating testing equipment and creating/documenting test procedures

Additional

• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.
• Experience with project management (for example planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives).
• Position may require travel up to 10% of the time for business purposes (within state and out of state).

PREFERRED QUALIFICATIONS:
Relevant Work Experience

• At least 3 years of experience in the development and launch of new medical/pharma products.

Certification / Licensure

• Six Sigma or Lean Certification.

Additional

• Experience utilizing Minitab to perform analysis of test data.
• Experience with CAD systems, FEA, Six Sigma, ANDA, ISO/CE Mark, GLP, GMP, GDP, USP testing, and high volume manufacturing processes.

Job Type: Full-time

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