Operations Product Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Hybrid role based in Marlborough, Massachusetts or New York, New York, with in-office collaboration Tuesday through Thursday and remote work potentially available Monday and Friday. Must be authorized to work full-time in the United States; domestic and international travel up to 15% may be required.
Salary: $84,000–$100,000 annually, plus bonus.
Company
is a global consumer products company whose brands include Braun and Vicks, developing products for consumers across multiple markets.
What you will do
- Own sustaining engineering activities for assigned Braun and Vicks consumer medical products.
- Develop test plans, review test reports and process validation documents, and draft technical memos.
- Maintain design history files and assess product changes for verification, validation, and documentation needs.
- Conduct component and system failure analysis and lead technical reviews and verification testing.
- Collaborate with engineering, program management, regulatory, quality, supply chain, marketing, and accredited test laboratories.
- Support testing and regulatory compliance activities, including biocompatibility, electrical safety, and performance evaluations.
Requirements
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field.
- At least 2 years of experience in sustaining engineering, product development, and/or manufacturing within a regulated industry.
- Experience with healthcare consumer products, consumer electronics, medical devices, or similar electromechanical products.
- Knowledge of ISO 13485 and IEC 60601 standards.
- Proficiency with CAD tools such as SolidWorks or Creo, prototyping, and 3D printing.
- Experience with injection molding, sheet metal fabrication, silicone molding, and die casting, plus the ability to travel up to 15% and work in the United States.
Nice to have
- Familiarity with software and firmware development concepts.
- Understanding of UL, ETL, FDA, CE, and NMPA requirements.
- Hands-on circuit design and PCBA experience.
Culture & Benefits
- Flexible hybrid work model supporting collaboration and productivity.
- Healthcare, dental, and vision coverage.
- Paid holidays, paid parental leave, paid time off, and paid charitable leave.
- 401(k) with company match and life and disability insurance.
- Educational assistance and a collaborative, inclusive workplace.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →