Product Development Engineer II
2 days ago
We are seeking a highly skilled Product Development Engineer II to join our team at Quality Tech Services, LLC. As a key member of our engineering team, you will be responsible for designing and developing new medical device packaging solutions that meet the highest standards of quality and safety.
Key Responsibilities- Analyze and interpret customer requirements and specifications to propose new packaging designs and end-of-line services.
- Create and update design documentation, including bill of materials, process flows, and control plans.
- Assess the feasibility of new project opportunities and work with cross-functional teams to build project proposals and production quotes.
- Plan and manage technical aspects of new product initiation project plans and timelines.
- Write project Master Validation Plan summaries and plan, execute, and own package design validations.
- Work with suppliers and supplier quality to create QTS receiving inspection plans and component qualification plans.
- Review and assess changes to ensure continued compliance to customer requirements.
- Provide product line and customer guidance to quality, production, supply chain, and other teams.
- Bachelor's degree in engineering (Biomedical, Mechanical, Packaging, or a related field).
- 5 years of experience as an engineer in the medical device industry or similar role.
- Knowledge of commonly used concepts, practices, and procedures in medical device end-of-line manufacturing.
- Basic proficiency with CAD software for design purposes and previous technical writing experience.
- Awareness of standard statistical techniques and ability to read, understand, and interpret regulations and technical standards.
- Effective verbal and written communication skills and ability to work well in team-oriented environments.
At Quality Tech Services, LLC, we offer a comprehensive benefits package, including medical, dental, vision, and life insurance options, a 401(k) retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off, and holiday pay. We also offer company-specific benefits, such as free parking, employee appreciation events, volunteer opportunities, training and development opportunities, tuition reimbursement, and annual flu vaccination clinics.
We are an equal opportunity employer and welcome applications from diverse candidates. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees.
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