Principal Product Development Engineer

Company: System One
Location: Somerville
Posted on: June 19, 2022

Job Description:

Principal Product Development Engineer

Degree:
- BA degree is required

Experience/"MUST HAVES":
- 10+ yrs. engineering experience is required
- Broad knowledge of principles, practices' and procedures in disposables medical device development. This includes the regulatory environment within the US and EU and functional/driving aspects of QMS and cGMP
- Strong project management and leadership skills

Duties/Responsibilities:
- Oversees disposables R&D product development projects and technical efforts of project execution as a senior contributor within the R&D organization
- In managing the project (1-3 engineers assisting in the projects, and individually contributing on project deliverables), the project manager is technically knowledgeable on the products being introduced or changed, and becomes a subject matter expert in manufacturing and commercial aspects of the product's life cycle
- Role includes responsibility for large-scale new product development and sustaining development for commercialized products that require significant technical oversight. The role will be high-visibility and impactful to the business and customers
- This is a collaborative and highly impactful role responsible for managing all the technical aspects and cross-functional deliverables of the projects. This role also involves building and leading cross functional teams to achieve the project objectives for the products under development
- Successful Principal Engineer establishes high-quality product specifications that enable long-term sustaining engineering projects to maintain the appropriate level of product performance and quality characteristics during future cost-reduction and feature-altering change projects. Additionally, manages the delivery of whole projects in accordance with business objectives, provides executive reporting on project status, and resolves project/program issues with a high level of performance

Location: Boston, MA area
Start Date: ASAP!
Duration: Direct Hire

Keywords: System One, Somerville , Principal Product Development Engineer, Engineering , Somerville, Massachusetts