Vacancy expired!
- This role will provide subject matter expertise (SME) in the areas of:
- Biological/microbiological and analytical testing development and methodologies for medical devices, materials and combination products.
- Including leading and supporting routine and non-routine USP, ASTM, ISO, and CLSI based microbiological testing for anti-infective, antiseptic, or disinfectant efficacy (i.e., time-kill assay, MIC/MBC, sterility testing, microbial limits, bioburden, neutralization validation).
- Develop test methods and craft requirements in the subject matter area which follow innovative and industry practices and standards not limited to USP, ASTM, ISO and CLSI.
- Apply rigorous and innovative approaches for development of microbiological, biological and analytical test methods for novel and non-compendial product evaluations.
- Understand and proliferate best practices as it relates to biological/microbiological testing.
- Serve as organizational SME for:
- Biological/Microbiological test method validation
- Regulatory and organizational strategies as they relate to Biological/Microbiological requirements and test methods
- Support preparation of responses to regulators
- Statistical analysis of method outputs, sample sizes related to and used in method validation.
- Plan and support through all project phases with a focus on the strategy and execution of design and development, measurement system development/qualification, design verification and design validation.
- Independently support product development projects and optimally define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
- Craft, edit, and interpret technical drawings and technical reports and write protocols, reports, work instructions, presentations, etc.
- Expertly apply engineering principles for design/analysis and complete statistical analysis and sample plan development.
- Demonstrate accountability for the successful and timely achievement of goals.
- Present to peer and stakeholder audience on are of expertise to empower the organization and disseminate data and conclusions
- Minimum 5-6 years of experience in medical device or other regulated industry OR Master's Degree in Mechanical/Biomedical/Bioengineering Engineering and 3+ years of experience OR PhD in Mechanical/Biomedical Engineering/Biology and 3+ years of experience.
- Expertise with biological and microbiological testing of medical devices, associated lab practices and standards is required.
- Expertise with test method development, validation strategy, and validation execution is required.
- Expertise with design verification & validation strategy development and execution is required.
- Consistent track record of technical problem solving and effective product development through experienced application of engineering/biology principles is required.
- Design controls expertise and experience with traditional and modern fabrication techniques is a plus
- Experience in packaging testing methodologies and industry standards is a plus
- Experience in solid modeling (SolidWorks) or electromechanical systems is a plus.
- Experience in high-volume manufacturing processes is a plus.
- Experience developing and commercializing medical devices is a plus
- Exposure to Chemistry/ Chemical Engineering is desirable.
- Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and implement initiatives.
- Strong interpersonal and decision-making skills and the ability to effectively lead change and uncertainty.
- Ability to engage and mentor team members and to enhance diverse perspectives to achieve the best outcomes.
Vacancy expired!