Lead Technique IA responsible for designing and implementing AI and BI solutions at Genia. Supporting clients in their digital transformation while leveraging cloud services and data engineering practices.
About the role
- Associate Staff Engineer in product development at BD focusing on cost-effective solutions and regulatory compliance in medical technology. Leading value engineering initiatives and collaboration across teams.
Responsibilities
- Lead cross-functional value engineering initiatives to identify and implement cost-saving opportunities without compromising product quality or performance.
- Represent the R&D function while collaborating with Quality, Regulatory, and Manufacturing teams to ensure concepts meet the Design Input’s defined for the product.
- Analyze product designs and specifications to identify opportunities for simplification, standardization, and material optimization.
- Develop and maintain design control documentation including design history files (DHF), risk management files, and verification/validation protocols.
- Drive design reviews and facilitate root cause analysis for design-related issues.
- Support regulatory submissions by ensuring design documentation meets FDA, ISO 13485, and other applicable standards.
- Mentor junior engineers and provide technical leadership in value engineering and design control best practices.
- Utilize tools such as DFMEA, PFMEA, CAD, and PLM systems to support engineering decisions.
- Stay current with industry trends, materials, and technologies to continuously improve product design and cost efficiency.
Requirements
- Bachelor's or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
- 8 years of experience in product development, value engineering, and design control within a regulated industry (medical devices preferred).
- Deep understanding of design control requirements under FDA 21 CFR Part 820 and ISO 13485.
- Proven track record of leading successful value engineering projects with measurable cost savings.
- Strong analytical and problem-solving skills with proficiency in engineering tools and software.
- Excellent communication and leadership skills with the ability to influence cross-functional teams.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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