Sr R&D Engineer

Description

Summary:

The Senior R&D Engineer is a hands-on technical contributor who independently leads the design, development, and transfer to manufacturing of catheter-based medical devices, components, and assemblies for LightningCath customers. Working under general direction, this role takes products from concept and feasibility through design verification and process validation, applies a working knowledge of polymer materials and catheter construction methods, owns defined project workstreams, and provides technical direction to technicians, operators, and less experienced engineers.

Essential Duties and Responsibilities (but are not limited to):

• Designs and develops catheter shafts, components, and assemblies, including material selection and construction methods such as extrusion, braiding, coiling, reflow/lamination, tipping, bonding, and forming.
• Builds and iterates prototypes hands-on in the lab; designs and builds test fixtures, tooling, and assembly aids.
• Creates and maintains 3D CAD models and released drawings with appropriate tolerancing and GD&T.
• Develops and qualifies test methods (e.g., tensile, torque, kink, burst, flow, track/push, dimensional) and executes design verification testing, analyzing results with appropriate statistical methods.
• Establishes new and/or improved processes based on product and design criteria.
• Develops manufacturing procedures and travelers, performs process characterization, and aids in process validation (IQ/OQ/PQ) to transfer processes to manufacturing.
• Works within the team environment to solve quality and design issues, leading root cause investigations and supporting NCMR and CAPA activities.
• Provides technical guidance and work direction to technicians and operators, and mentors junior engineers.
• Works directly with customers to define requirements, communicate technical status, and meet their deliverables and timelines.
• Takes part in the business development process, especially new product introduction for new and existing customers, by scoping technical work and estimating effort for customer proposals.
• Works with suppliers to source and qualify materials, components, and outside processes.
• Maintains knowledge of new developments in catheter materials, manufacturing, and design technologies.

Requirements

Education/Experience:

• Bachelor’s degree in Mechanical, Biomedical, Plastics/Polymer, or related engineering discipline.
• 5+ years of engineering experience.
• 3+ years of medical device product development experience, with hands-on catheter design or process development strongly preferred.

Knowledge, Skills, and Abilities:

Required

• Proficiency in 3D CAD for part and assembly modeling and drawing creation.
• Working knowledge of catheter materials (e.g., Pebax, nylon, polyurethanes, PTFE, polyimide, stainless steel, nitinol) and catheter construction and assembly processes.
• Working knowledge of design controls, risk management, and quality system requirements under ISO 13485, 21 CFR 820 (QMSR), and ISO 14971.
• Experience writing and executing test protocols and reports, and applying statistical analysis to engineering data.
• Strong technical writing and verbal communication skills, including direct communication with customers.
• Ability to manage multiple projects and priorities in a fast-paced, small-company environment.

Preferred

• Experience with Onshape and SolidWorks.
• Experience with 3D printed parts and assemblies.
• Experience in a contract design and manufacturing (CDMO) or customer-facing development environment.
• Experience with process validation (IQ/OQ/PQ) and transfer of processes to manufacturing.
• Familiarity with sterilization (EO, gamma) and biocompatibility (ISO 10993) considerations as they affect design and material selection.
• Experience with statistical software (e.g., Minitab) and design of experiments (DOE).
• Lean, Six Sigma, or DFM/DFA training.

Working Conditions:

• Work is performed in an office, laboratory, and cleanroom manufacturing environment; must be able to follow gowning and cleanroom procedures.
• Fine manual dexterity and close visual work, including use of microscopes, for prototyping and assembly.
• Occasional travel to customer and supplier sites (up to approximately 10%).

Summary of Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan).
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Short Term Disability (STD).
• 401(k) Plan with company match
• Paid Time Off
• Paid Parental Leave
• Paid Holidays
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

• The typical base pay range for this role is between $105,000-140,000/year. Actual compensation will be based on individual job-related knowledge, skills, expertise, and experience.