Sr Product Development Engineer

Acumed LLC

Come join a team where People make the difference!As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope

The Product Development Engineer is responsible for the development of a product from concept to commercialization. This includes research, planning, idea creation and realization, concept development, specification generation, maintenance of product designs, testing and validation protocols, as well as effective communication with team members, management, and customers.

Duties/Responsibilities

• Manages and delegates tasks to junior engineers and product designers.
• Leads medium to large cross-functional projects.
• Presents to management teams, influencing key decisions.
• Builds relationships with HCPs and sales personnel.
• Defines test methods, protocols, and experimental designs.
• Manages external testing houses.
• Establishes mechanical and clinical correlations for test methods.
• Utilizes CAD/Windchill for design elements and standards.
• Applies advanced FEA for risk and failure mode analysis.
• Conducts IP research and submits patent applications.
• Utilizes RCA tools for complex issues and leads investigation teams.
• Works with Quality to define risk inputs to Risk Management Report (RMR).
• Applies clinical research data to DCTM criteria.
• Organizes and conducts cadaver labs with surgeons.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Bio-Mechanical Engineering, or equivalent with 5 years of experience preferred, or 11 years in medical device development.
• Proficient in managing junior staff and multiple vendors.
• Demonstrated ability to lead PDTs, manage project schedules, and meet deadlines.
• Develops design solutions for complex problems with minimal supervision.
• Proficient in creating test protocols and correlating methods to clinical relevance.
• Proficient in applying DFM principles.
• Skilled in 3D tolerance stack analysis preferred.
• Knowledgeable of 510(k) and CE marking processes.
• Applies advanced FEA for complex risk mitigation.
• Conducts patent landscape analysis and navigates patent applications.
• Proficient in supporting product management and sales events.
• Co-authors risk management documents with quality.
• Applies statistical tools to analyze results.
• Proficient in at least one technical specialty area.
• Applies clinical outcome data to DCTM criteria.

Target Compensation: $115,164.45 – $140,756.55

Benefits: Medical, Dental and Vision insurance, 401k matching, + more.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.