The Technical Lead, Product Development provides technical leadership for medical-device and combination-product prototyping and feasibility activities. This role applies expertise in mechanical, plastic, electrical, software, human factors, and usability engineering to develop integrated product solutions. The Technical Lead resolves technical challenges, influences cross-functional decisions, and considers the impact of development activities on design controls, verification and validation, risk management, and regulatory submissions. Responsibilities • Lead prototyping and feasibility activities for medical-device and combination-product programs. • Develop and evaluate product concepts, prototypes, designs, and technical solutions. • Apply expertise in mechanical and plastic-part design, injection molding, DFM, DFA, DFx, and tolerance analysis. • Collaborate with electrical, software, systems, human factors, quality, regulatory, and manufacturing partners. • Support the development, integration, and testing of electrical hardware and device software. • Resolve technical challenges and design tradeoffs using engineering judgment and data analysis. • Plan, execute, analyze, and document feasibility studies and prototype evaluations. • Apply knowledge of design controls, ISO 14971, ISO 13485, DHF documentation, and design verification and validation. • Assess how technical decisions and design changes may affect product requirements and regulatory submissions. • Lead cross-functional technical discussions and influence decisions without direct authority. Qualifications • BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline. • Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies. • Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals. • Recognized and sought out as an expert in his/her discipline within the company and possibly externally. • Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents. • Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographiclocation, and we may ultimately pay more or less than the posted range. This range may be modified in the future. • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. • This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability ofany bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company'ssole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.