Design Engineer
3B Staffing LLC
Responsibilities
- Develop quality assurance documentation for new product development and regulatory submissions.
- Maintain quality system for design control by identifying and correcting deficiencies.
- Engage in design, development, manufacturing, and risk management activities.
- Participate in design reviews, identifying risks and tracking mitigation measures.
- Define design verification and validation test requirements and complete reports with statistical validity.
- Support Advanced Operations in developing manufacturing processes for new products.
- Utilize statistical analysis and problem-solving techniques to determine product acceptance limits and resolve quality issues.
- Develop, review, and approve inspection plans, routers, and product drawings.
- Support product design transfers to manufacturing facilities.
- Evaluate predicate products for relevant quality issues impacting new product development.
- Analyze and define critical quality attributes through risk analysis techniques.
- Collect initial market feedback and address early concerns.
- Lead risk management activities by developing risk management plans and conducting risk reviews.
- Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
- Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
- Ability to read and interpret CAD drawings.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Thorough knowledge of US and International Medical Device Regulations.
- Strong project management skills and ability to manage multiple tasks.
- Advocacy for product excellence and quality.
- Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
- Strong interpersonal, written, oral communication, and negotiation skills.
- Critical and 'outside the box' thinking.
- Problem-solving and analytical skills.
- Ability to manage and complete projects in a matrix organization.
- Ability to work independently.
- Experience in compliance risk situations.
- Computer literacy, including proficiency with Mini-Tab or similar analysis programs.
- Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.
- Demonstrated ability to effectively manage multiple tasks simultaneously.
- Demonstrated ability to advocate for product excellence and quality.
- Strong interpersonal skills and ability to work cross-functionally.
Vacancy posted 3 days ago
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