Responsibilities Device Design:

Design precision mechanical components, optical mountings, ergonomic enclosures, chassis assemblies, and moving mechanisms for medical diagnostic instrumentation using 3D CAD tools.

Engineering Drawings & Documentation:

Create, release, and maintain detailed 2D production drawings.

Prototyping & Additive Manufacturing:

Manage and operate internal 3D printers and rapid prototyping equipment to produce functional proof-of-concept models, visual prototypes, and test fixtures.

New Product Introduction & Production Transfer:

Lead mechanical design transfer activities into manufacturing, establishing Assembly Work Instructions (AWIs), Bill of Materials (BOM) structures, initial tooling requirements, and production routing.

Design Controls & Quality Compliance:

Generate design control documentation under ISO 13485 and MDSAP, including engineering change orders and component specifications.

Manufacturing & DFM Integration:

Collaborate with external vendors (machining, plastic molding, sheet metal fabrication) to ensure Design for Manufacturability and Assembly and support successful transition from development to production.

Sustaining Engineering & Manufacturing Support:

Provide ongoing technical support to internal production operations and contract manufacturers, driving root-cause failure analysis (CAPA/NCR) and implementing engineering changes to improve yield and assembly throughput.

Cross-Functional Collaboration:

Coordinate with electrical, optical, and software engineering teams to ensure seamless integration of electronics, displays, sensors, cabling, and user interface elements within mechanical enclosures. 3.

Education Required:

Bachelor of Science (BS) degree in Mechanical Engineering, Biomedical Engineering (with an electrical focus), or a closely related discipline from an accredited university. 4.

Requirements & Technical Skills CAD Experience:

Experience using 3D CAD software for parametric complex part modeling, large assemblies, surfacing, and drawing generation.

Prototyping Expertise:

Hands-on experience with additive manufacturing technologies and standard machine shop equipment (mill, lathe, hand tools) for rapid iterative design.

Documentation Control & PLM Systems:

High proficiency in formal document control practices, configuration management, structuring multi-level Bills of Materials, and processing Engineering Change Orders.

Manufacturing Transfer & DFM Support:

Strong working knowledge of Design for Manufacturability, Assembly, and Serviceability; direct experience establishing production assembly work instructions, alignment jigs/fixtures, and supporting design transfer to internal operations or contract manufacturers.

Materials & Manufacturing Processes:

Working knowledge of engineering plastics, biocompatible materials, metals/aluminum alloys, sheet metal fabrication and precision machining techniques.

Communication & Collaboration:

Strong technical writing and communication skills; ability to document technical work clearly and collaborate seamlessly across R D, Quality, and Operations teams. 5. Experience 5+ years of direct mechanical engineering experience in product development, ideally within the medical device, diagnostic instrument, optical hardware, or life science industries. Demonstrated experience taking mechanical products or sub-assemblies through the full development lifecycle—from early-stage conceptualization through verification testing and production release. Familiarity with medical device quality standards (ISO 13485, ISO 14971, IEC 60601-1 safety standards) is desirable.

Pay:

$65,000.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance

Work Location:

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