Systems Engineer - Medical Device Development

Systems Engineer - Medical Device Development

Vacancy expired!

Job Description

Are you tired of working on the same old products? We are currently seeking a qualified

Systems Engineer for our Medical Development segment. This is a highly technical role supporting our project managers. You will be involved in developing specifications, concept/system architecture, engineering and design, and build/testing activities with some or all our engineering disciplines.

Job Responsibilities:

To be successful in this role you will have technical accountability for the project from start to finish. As the cross-discipline technical authority, you would be responsible for the project deliverables meeting requirements. Other responsibilities include:

Develop and specify operational, functional, and design requirements to meet customer needs

• Customer interactions and translation of customer needs to product/project requirements
• Promote cross-discipline discussion and trade-offs
• Perform simulations and analyses
• Investigate applicable normative requirements (ISO, CE, UL, RoHS, WEEE, etc.) as required
• Define product architectures with an emphasis on interfaces

Work with engineering discipline leads to build engineering project plans

• Lead cross-functional teams in project execution
• Coordinate cross-discipline analyses and assessments
• Safety Analysis
• Identification of technical risk areas and mitigation strategies
• Failure modes and effects analysis (FMEA)
• Design for X (DFX)

Responsible for design review content

Coordinate the integration, debug, and test of engineering prototypes

Responsible for the test strategy

• Coordinate the development of test plans and procedures
• Oversee both verification and validation testing
• Promote use of, and assist in improvements with Boston Engineering processes and its Quality Management System (QMS)

Requisite Skills:

• Multi-discipline product development experience on complex systems
• Team leadership experience for complex electromechanical project development
• Strong technical leadership skills
• Excellent written and verbal skills

Qualifications

• 10+ years multi-discipline product development experience on complex systems
• Well versed in at least two technical disciplines and conversant in all
• Background in a fast-paced technical consulting or services environment
• Prior experience in medical product development
• Working knowledge of the Medical Device standards: ISO 13485, 14971, IEC 62304
• Minimum of a BS degree in Mechanical, Electrical, or Software engineering – MS preferred

Additional Information

Your application will not be considered complete without a writing sample attached to it.

We offer a hybrid work environment that encourages our team to cross-train, pursue inspiring and innovative engineering, and experience a broad depth and breadth of opportunities. We offer an open, energetic working environment that fosters an entrepreneurial team spirit. Founded in 1995, we are located in Waltham, MA.

All your information will be kept confidential according to EEO guidelines.