Location
Marlborough, MA | United States
Job description
Join our Engineering Team as our Sr. Project Engineer (hybrid work onsite and from home), and make an immediate impact on our Beauty & Wellness trusted brands. Together, we build innovative and useful products that elevate people's lives everywhere every day!
The Senior Project Engineer will be the primary point source for evaluation of the design of proposed medical device products along with development and evaluation of such products. This role will also be responsible for development of Verification and Validation methods for medical products to ensure they meet intended use needs in addition to specification needs. Evaluations of the practicality from a Biomedical viewpoint will be required and a background in Biomed engineering is strongly preferred.
A major component of this role will be to fulfill project engineer responsibilities on a per-project basis, including the creation and maintenance of DHF documentation and oversight of technical resolution activities.
- Maintain and create Design History Files and reports in the role of project engineer
- Senior Technical Lead across multiple programs working to tackle product design development problems and improvements.
- Work with engineering and marketing teams on new product development and sustaining engineering
- Investigation/understanding of leverage/competitive designs
- Perform component and system failure analysis with Quality
- Develop, support, or perform usability studies to test new insights and concepts
- Work with Regulatory to develop and support new clinical studies
- Support 510K and CE registration filings with Regulatory
- Interface and work with other members of the multi-functional team, including electrical and software engineers, marketing, sales, and operations
- Lead and develop technical reviews, testing verifications, and systems and functions
- Work with outside testing houses for compliance testing (biocompatibility, safety, performance, FDA, etc.)
- Own the technical design of product components based upon design requirements
Minimum Qualifications:
- Bachelor's degree in Bio Medical, Mechanical or Electrical Engineering; or similar field
- 5 years of experience conducting product development in a regulated industry
- 5 years of experience in consumer product development
- Experience drafting formal Verification and Validation plans for hardware and software
- Capable of preparing formal review reports for proposed projects
- Experience leading product development activities in all phases of the NPD process, including technical feasibility, prototyping, testing, designing, and performance, and feature validation and verification through pilot run and initial production
- Understanding of small device design, manufacturing and other practices including plastic design and molding for electrical/medical devices
- Strong written and verbal communication skills. Must have the ability to provide concise and accurate status and direction on projects
- Solid understanding of UL/ETL/FDA/CE general requirements
- Ability to travel up to 5 -10%; some international travel
- Authorized to work in the United States on a full-time basis
Benefits - Outstanding medical coverage
- 401k match
- 10% annual bonus
- True catering to a work life balance
- Hybrid work schedule
Applicants must be authorized to work in the U.S.
Preferred Skills
Product Development
Engineering
Verification
Manufacturing
Medical Device
Electrical Component
circuit design
PCBA
Job tags
Salary
$115k - $130k
