Sr. Engineer – Disposables R&D, NPD (hybrid)
About The Position
Supports new product development initiatives for disposable medical devices. This role involves supporting or leading projects with global cross-functional teams for the development of new disposable products or product extensions. The engineer will develop user needs and translate them into product requirements, identify, investigate, and solve engineering problems using risk-based and customer-focused approaches and engineering tools. They will also create, modify, and maintain design history file documentation, develop and execute test method validations, product testing, and verification/validation activities. Additionally, the role includes building prototypes and models, and potentially operating machine tools, designing and building basic tooling, test fixtures, and assembly equipment. Adherence to design control procedures, safety rules, company policies, and FDA and international regulations is required.
Requirements
- BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
- 3 – 5+ years of related experience in Class II or Class III disposables medical product development.
- Operating within a stage/gate based new product development process.
- Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
- Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks).
- Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
- Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
- Strong collaboration, verbal and written communication skills.
- Strong attention to detail, organized, and able to independently manage multiple priorities.
- Ability to read, write and comprehend English.
Nice To Haves
- Design for Six Sigma (DFSS) training or certification preferred
Responsibilities
- Support or lead projects, with global cross-functional teams, for the development of new disposable products or product extensions.
- Develop user needs and translate them into product requirements.
- Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
- Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.
- Develop and execute test method validations, product testing, and verification / validation activities.
- Build prototypes and models.
- May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.
- Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
Benefits
- medical coverage
- dental coverage
- vision coverage
- basic life insurance
- accident insurance
- short-term disability insurance
- long-term disability insurance
- business travel accident insurance
- Aon Pooled Employer Plan (“Aon PEP”)
- 401(k) retirement savings plan
- Flexible Spending Accounts
- educational assistance programs
- paid holidays
- paid time off ranging from 20 to 35 days based on length of service
- family and medical leaves of absence
- paid parental leave
- commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
