Job description

This position will report directly to the Vice President of R&D and will have direct accountability for program and project initiatives across the entire product portfolio. The ideal candidate has worked in medical device arena and has experience with devices in a regulated environment. We are looking for a highly motived person who is comfortable across multiple cross functional areas and has a solid understanding of how to navigate rapid change and quick to market activities.

Primary Responsibilities:

 Work across engineering functions to architect, design, and help direct the execution of assigned projects related to laser systems and accessories.

 Work cross-functionally (marketing, service, manufacturing, regulatory, and quality) to develop system architecture, specifications, verification testing and troubleshooting

 Work within engineering to translate product requirements (PRDs) into design specifications for assigned projects.

 Hands-on design of electronics that successfully integrate with electromechanical and software subsystems

 Act as a hands-on design engineer/contributor on assigned projects as needed (based on available department resources).

 Contribute to detailed design work associated with electrical/electronic, mechanical, or pneumatic subsystems.

 Create and maintain test protocols for design verification and validation activities on assigned projects as required.

 Oversee the execution of testing to prescribed protocols, documenting results and creating final reports on assigned projects (based on department resources).

 Create and maintain a traceability matrix between requirements, design, specifications, and testing for assigned projects.

 Work with the Product Management team to define and execute system integration activities and usability studies within projects.

 Prepare, present, and participate in comprehensive technical and/or design reviews.

Requirements:

 BS degree in Engineering or related technical discipline, advanced degree would be preferred.

 10+ years of Engineering experience preferably in the medical devices, product development and/or process development.

 Electronics and embedded systems architecture and circuit design

 Solid experience in designing for manufacture, test, cost, and reliability

 Knowledge of relevant standards including IEC 60601-1 (including Electrical Safety and EMC requirements), WEEE and RoHS requirements

 Knowledge of quality and regulatory requirements guiding medical device development, plus experience dealing with regulatory agencies or outside professional groups (e.g., FDA, ISO)

 Experience with optical and/or laser based system design.

 Experience with component/supplier selection process.

 Ability to integrate and correspond with external design firms to complete milestones.

 Strategic long term & short term thinking, ability to multitask with a sense of urgency

 Computer skills (especially MS Office, MS Project and Outlook)

Key Skills:

 Strong understanding of product development and ongoing manufacturing operations including process development, mfg. engineering, supply chain, sourcing, and production

 Experience in managing and working in a multidisciplinary team

 Knowledge of quality and regulatory requirements guiding medical device development, plus experience dealing with regulatory agencies or outside professional groups (e.g., FDA, ISO)

 Strategic long term & short term thinking, ability to multitask with a sense of urgency

Job Type: Full-time

Pay: Up to $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Waltham, MA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• medical device industry: 10 years (Preferred)
• embedded systems architecture and circuit design: 10 years (Preferred)
• product development: 10 years (Preferred)

Work Location: In person

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