Software Engineering Intern at Intapp working on AI - powered solutions and web applications. Collaborate with engineers, gain mentorship, and learn best practices in a hybrid environment.
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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