Senior Mechanical R&D Engineer

Stellartech Research Corp • Milpitas, CA

1d • $150,000 - $200,000

About The Position

We are seeking a hands-on Senior Mechanical R&D Engineer to assist with detailed design and development of novel medical devices to create tissue access and deliver therapy in minimally invasive environments. This role emphasizes early-stage R&D, intellectual property (IP) generation and design-around innovation, with a focus on miniature boring, cutting, steering and deployment mechanisms integrated into sterile single-use probes and catheter-based platforms.

Stellartech utilizes a ‘multi-physics’ approach to develop therapeutic medical systems, and integrates mechanical, electrical, and software-controlled elements that are optimized for the “clinical user environment”. The candidate will develop sophisticated medical devices from concept to market release. They will create and/or translate medical device product requirements into measurable engineering specifications, will help determine product and major sub-system performance requirements, and perform the development and/or sourcing of these elements. They will assist with all development activities required for clinical product use, including DMR creation, DHF preparation, product verification and validation testing, packaging design and verification, sterilization and biocompatibility validation, as well as assist with certification testing to internationally recognized Standards from ANSI/AAMI, ISO, ASTM, ASME, and the IEC. This is a technical leadership role for an engineer who thinks in mechanisms, materials, assembly methods, failure modes, and patent claims.

Requirements

• Bachelor's degree in Mechanical Engineering (Master’s or PhD strongly preferred).
• 12+ years of medical device R&D experience, including early-stage invention work and track record of successful product launches.
• Experience with catheter-based or probe-based delivery systems.
• Familiarity with dense tissue mechanics, cutting forces, and material interactions.
• Experience with rotational torque transmission in flexible or semi-flexible shafts.
• Familiarity with regulatory requirements pertinent to medical device development, including US FDA Quality System Regulations, 21 CFR Part 820, Design Controls and Good Manufacturing Practices (GMP’s), international standards such as EN 13485 and ISO 14971, etc.
• Advanced proficiency in 3D CAD (SolidWorks).
• Hands on experience with fabrication equipment, including mill, lathe, laser welder, boring, cutting, extrusion, injection molding, adhesive bonding, ultrasonics assembly, etc.
• Familiarity with engineering materials used is disposable medical devices.
• Familiarity with standard laboratory practices and test equipment, such as multimeters, oscilloscopes, tensile testers, strain gauges, pressure gauges, thermocouples, etc.
• Experience supporting IDE, 510(k), or PMA filings and with preparation of regulatory agency documentation to support approvals.
• Experience with transfer into manufacturing, including equipment, tooling and fixture design and fabrication, process development, operator training, process validation and manufacturing documentation, including Device Master Records, Manufacturing Procedures, Quality Instructions, and Test Procedures.
• Ability to communicate ideas and information clearly and effectively, i.e. good verbal and writing skills.
• Team-oriented professional with good interpersonal skills who is hands-on.

Responsibilities

• Create and/or translate customer requirements into measurable product specifications. Consider the application of collateral requirements, e.g., ASME fatigue requirements, IEC 60601 electrical safety requirements, etc.
• Design and develop mechanical systems to bore into, traverse, or access dense tissue in minimally invasive procedures with mechanisms that include rotational, axial and torque-transmitting, and deflectable deployment systems for catheter and probe-based devices.
• Perform detailed structural and fatigue analysis of the tissue-interacting components, such as boring tips, cutting features, cannula design, and their mechanical interfaces.
• Consider performance, risks, manufacturability, materials, surface treatments, coatings, sterilization methods, and biocompatibility appropriate for dense tissue contact and wear.
• Develop detailed CAD models, drawings, and specifications suitable for prototyping, manufacturing, assembly and inspection.
• Assist with patent landscape reviews, design-around analyses and IP defensibility related to device technologies. Design mechanical systems with claims scope in mind, including alternative embodiments. Drive multi-path concept exploration to avoid single-solution risk and strengthen patent coverage.
• Assist with benchtop, cadaver and in vivo testing in appropriate species to assess clinical and mechanical performance, including torque transmission, axial and radial load support, fatigue, wear, and failure-mode characterization.
• Complete development of the product and perform and/or direct design verification and validation activities.
• Collaborate with Quality Engineering, Systems, Electrical and Software Engineering, Legal/IP, Clinical, Regulatory, and manufacturing teams during concept development.
• Contribute to risk management activities (DFMEA, Usability and use-related hazards, mechanical failure modes, etc.).
• Support technology transfer to manufacturing, including DFM/DFA, supplier qualification, and first-article inspection.
• Provide technical mentorship and thought leadership within the R&D organization.

Benefits

• We offer a competitive benefits package to our full-time employees, including medical, dental vision, life and disability insurance, and paid time off.
• In addition, Stellartech offers a 401(k) plan with company match and a stock equity plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level