Elucent Medical, Inc.
Sr. Mechanical Engineering Manager
Elucent Medical, Inc., Eden Prairie, Minnesota, United States, 55344
Job Title:
Sr. Mechanical Engineering Manager
Department: Research and Development
Reports to: Chief Technology Officer
Work Location: In-Person
Pay Range: $130,000.00 to $170,000.00 Salary (Based on Experience)
Position Type and Expected Hours of Work: Full-Time, Monday-Friday, 40 hours/week
About Elucent Medical: Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.
Job Summary: The Sr. Mechanical Engineering Manager is responsible for leading the mechanical design and development of Elucent's medical device systems, ensuring the delivery of high-quality, manufacturable, and reliable mechanical solutions that align with business and clinical needs. This role oversees the mechanical engineering team, establishes best practices for mechanical product development, and drives innovation across projects. The ideal candidate will be experienced in developing Class II medical devices and have a deep understanding of product lifecycle, regulatory requirements, and cross-functional development environments.
Supervisory Responsibilities: Recruits, interviews, hires, and onboards new mechanical engineering staff. Oversees daily tasks, technical mentorship, and team development. Provides timely and constructive performance feedback. Conducts performance evaluations and disciplinary actions as needed.
Job Responsibilities: Lead the mechanical engineering team in the design, prototyping, analysis, and development of medical devices, with a focus on surgical navigation systems. Own and manage the mechanical development roadmap, ensuring timelines, deliverables, and quality standards are met. Collaborate with cross-functional teams including Systems Engineering, Software, Quality, Clinical, Regulatory, and Operations to define system-level requirements and translate them into mechanical design specifications. Ensure mechanical designs meet safety, usability, biocompatibility, and sterilization requirements per FDA, ISO, and other applicable standards. Drive mechanical design reviews, risk assessments (e.g., FMEAs), and design verification/validation activities. Develop and manage detailed project schedules, resource allocation, and risk mitigation plans. Champion design for manufacturability (DFM), design for assembly (DFA), and cost-effective engineering practices. Promote innovation through the generation and protection of intellectual property that supports business and product objectives. Maintain thorough design documentation in accordance with quality system regulations and design control procedures. Evaluate and implement emerging technologies, materials, and manufacturing processes relevant to medical devices.
Qualifications Education and Experience: Bachelor's degree in Mechanical Engineering or related field; MS preferred. 7-10 years of progressive experience in mechanical product development, preferably in medical devices or other regulated industries. Demonstrated experience managing mechanical engineers and leading multidisciplinary product development efforts.
Required Skills/Abilities: Strong technical expertise in mechanical engineering principles, including materials selection, mechanism design, thermal management, fluid dynamics, and finite element analysis. Proficient with CAD software (e.g., SolidWorks), GD&T, tolerance stack-up, and simulation tools. Deep understanding of the full product development lifecycle in a regulated industry. Experience with design control documentation, risk management, and validation protocols. Proven track record of delivering complex mechanical systems from concept to commercialization. Exceptional project management, organizational, and leadership skills. Excellent written and verbal communication abilities, including technical documentation and executive reporting. Comfortable collaborating across engineering, clinical, and manufacturing teams to ensure product success.
Physical Requirements / Work Conditions: Ability to work in office, engineering lab, and manufacturing support environments. May require occasional lifting of equipment up to 25 pounds. Frequent use of standard office and engineering tools. Occasional travel to suppliers, contract manufacturers, or partner facilities (up to 20%).
Elucent Medical Benefits, Culture and Work Environment At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.
Fulltime Employees are provided: 401(k) 401(k) matching (4%) Dental insurance Health insurance Vision insurance Paid Holidays Paid Vacation Days Paid Sick Days Short Term Disability Long Term Disability Life Insurance Pet Insurance Employee Assistance Programs
Affirmative Action / EEO Statement Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Department: Research and Development
Reports to: Chief Technology Officer
Work Location: In-Person
Pay Range: $130,000.00 to $170,000.00 Salary (Based on Experience)
Position Type and Expected Hours of Work: Full-Time, Monday-Friday, 40 hours/week
About Elucent Medical: Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.
Job Summary: The Sr. Mechanical Engineering Manager is responsible for leading the mechanical design and development of Elucent's medical device systems, ensuring the delivery of high-quality, manufacturable, and reliable mechanical solutions that align with business and clinical needs. This role oversees the mechanical engineering team, establishes best practices for mechanical product development, and drives innovation across projects. The ideal candidate will be experienced in developing Class II medical devices and have a deep understanding of product lifecycle, regulatory requirements, and cross-functional development environments.
Supervisory Responsibilities: Recruits, interviews, hires, and onboards new mechanical engineering staff. Oversees daily tasks, technical mentorship, and team development. Provides timely and constructive performance feedback. Conducts performance evaluations and disciplinary actions as needed.
Job Responsibilities: Lead the mechanical engineering team in the design, prototyping, analysis, and development of medical devices, with a focus on surgical navigation systems. Own and manage the mechanical development roadmap, ensuring timelines, deliverables, and quality standards are met. Collaborate with cross-functional teams including Systems Engineering, Software, Quality, Clinical, Regulatory, and Operations to define system-level requirements and translate them into mechanical design specifications. Ensure mechanical designs meet safety, usability, biocompatibility, and sterilization requirements per FDA, ISO, and other applicable standards. Drive mechanical design reviews, risk assessments (e.g., FMEAs), and design verification/validation activities. Develop and manage detailed project schedules, resource allocation, and risk mitigation plans. Champion design for manufacturability (DFM), design for assembly (DFA), and cost-effective engineering practices. Promote innovation through the generation and protection of intellectual property that supports business and product objectives. Maintain thorough design documentation in accordance with quality system regulations and design control procedures. Evaluate and implement emerging technologies, materials, and manufacturing processes relevant to medical devices.
Qualifications Education and Experience: Bachelor's degree in Mechanical Engineering or related field; MS preferred. 7-10 years of progressive experience in mechanical product development, preferably in medical devices or other regulated industries. Demonstrated experience managing mechanical engineers and leading multidisciplinary product development efforts.
Required Skills/Abilities: Strong technical expertise in mechanical engineering principles, including materials selection, mechanism design, thermal management, fluid dynamics, and finite element analysis. Proficient with CAD software (e.g., SolidWorks), GD&T, tolerance stack-up, and simulation tools. Deep understanding of the full product development lifecycle in a regulated industry. Experience with design control documentation, risk management, and validation protocols. Proven track record of delivering complex mechanical systems from concept to commercialization. Exceptional project management, organizational, and leadership skills. Excellent written and verbal communication abilities, including technical documentation and executive reporting. Comfortable collaborating across engineering, clinical, and manufacturing teams to ensure product success.
Physical Requirements / Work Conditions: Ability to work in office, engineering lab, and manufacturing support environments. May require occasional lifting of equipment up to 25 pounds. Frequent use of standard office and engineering tools. Occasional travel to suppliers, contract manufacturers, or partner facilities (up to 20%).
Elucent Medical Benefits, Culture and Work Environment At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.
Fulltime Employees are provided: 401(k) 401(k) matching (4%) Dental insurance Health insurance Vision insurance Paid Holidays Paid Vacation Days Paid Sick Days Short Term Disability Long Term Disability Life Insurance Pet Insurance Employee Assistance Programs
Affirmative Action / EEO Statement Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.