Job description

This position will report directly to the Vice President of R&D The ideal candidate has worked in medical device arena and has experience with the expansion of devices in a regulated environment. We are looking for a naturally collaborative 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 within our multi-disciplinary team to define, design, build, and test new products across the lifecycle from initial conception to production
? Develop testing processes, and perform testing and validation of new designs
? Generate working prototypes for beta testing, design the architectural layout and detailed plastic and metal components
? Perform engineering calculations to support design work
? Create and review technical drawings, plans, and specifications using Solidworks
? Perform detailed documentation to track project development and design process
? Ensure project timeline is met and project stays within budget
? Support evaluating, characterizing optical elements, components, and fixtures. Modeling, prototyping, evaluating, and characterizing optical elements and mounts for next generation optical systems
? Execute new optical designs with a focus on manufacturability
? Perform analysis of optics, mounting strategies, detailed geometric tolerances, manufacturability, and cost.
? Support manufacturing engineering as necessary and provide appropriate tools and techniques to the service organization
? Collaborate with multi-disciplinary engineering teams, and work with vendors and contractors
? Adhere to best practices for documentation.

Requirements:
? Bachelors degree in Mechanical or Biomedical Engineering; Masters preferred.
? 5-7 years hands-on design, experience in product design and development in related field.
? Firm grasp of engineering concepts, and experience designing mechanical systems and products
? Strong experience using CAD software such as Solidworks, or similar
? Knowledge of GD &T including True Position methods, and drawing creation per ASME Y 14.5 2009
? Familiarity with production processes such as machining, injection molding and sheet metal as well as prototyping techniques such as 3D printing, laser cutting, and urethane casting.
? Strong knowledge of mechanical engineering fundamentals and manufacturing techniques, including DFM
? Experience with process fixturing and optical system calibration
? Proficient with laboratory instrumentation

Key Skills:
? Strong understanding of engineering operations including process development, mfg. engineering, supply chain, sourcing, and production
? Knowledge of quality and regulatory requirements guiding medical device development, plus experience dealing with regulatory agencies or outside professional groups (e.g., FDA, ISO 13485 Standards)
? Strategic long term & short term thinking, ability to multitask with a sense of urgency

Job Type: Full-time

Pay: $130,000.00 - $140,000.00 per year

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• 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: 5 years (Preferred)
• mechanical engineering: 5 years (Preferred)
• full life cycle of product development: 5 years (Preferred)
• working with optics/lasers: 5 years (Preferred)

Work Location: In person

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