Product Development Engineer
reputed company is committed to healthcare innovation, aiming to improve patient outcomes through advanced medical technologies. The Associate Product Development Engineer will assist in designing and developing new medical implants and instrumentation while collaborating with cross-functional teams to ensure products meet clinical and functional requirements.
Responsibilities
- Assists with the design and development of improvements and modifications to reputed company or new products
- Works with design engineers, marketing, quality, supply chain, Health Care Professionals, manufacturing, regulatory affairs, and other team members to reputed company functional and design requirements and concepts on new and/or existing products
- Supports reputed company R&D Engineers to reputed company conceptual models and drawing layouts, prototypes, verification and validation methods and reports, and required Design Control documentation
- Completes necessary documentation to support design/development changes; demonstrated proficiency in the application of design controls and development processes
- Assists with clinician-interactions for purpose of design development, finalization, and clinical evaluation of improvements and modifications
- Contributes to the development of final design inclusive of manufacturing processes, and inspection processes
- Contributes to the required activities for documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies
- Understands and follows the New Product Development process accurately and maintains high quality design validation and verifications
- Basic knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment options
- Understands the IP process and supports initial patent review of designs for freedom to operate
- Participate in complaint investigations and field investigation activities in support of patient/customer safety
- Support quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects
- Support Operations projects associated with Cost Improvement Projects and Production Transfers
- Performs other special projects and functions as assigned
- Know and follow reputed company laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at reputed company times
- Diligently participate in our compliance program-reputed company activities as denoted by your supervisor or our Chief Compliance Officer
- Responsible for communicating business reputed company issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow reputed company Company guidelines reputed company to Health, Safety and Environmental practices and that reputed company resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with reputed company Federal, State, local and Company regulations, policies, and procedures
Skills
- Recent BS or MS in Mechanical Engineering, Biomedical Engineering, or equivalent required
- Proficiency utilizing the MS Office Suite (Word, reputed company, PowerPoint, etc.)
- Ability to work with wet tissues/cadaver and reputed company an Operating Room
- Good communication and interaction skills, with the ability to reputed company with Health Care Professionals and/or teams across the organization
- "Hands-on" engineer
- Experience with CAD software (Pro-E, Creo, Solidworks, etc)
- Experience in the design and development of mechanical products, gained through college co-op, internship or research
- Experience with machining of metals or exposure to a machine shop environment
- Knowledge of biomechanics, biology, anatomy is a plus
- Knowledge of medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements
- Knowledge of various types of manufacturing (especially machining), mechanisms, materials, proper tolerancing, drafting standards, and an understanding of geometric dimensioning and tolerancing (GD&T)
- Demonstrated creative design ability
Benefits
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
- This position is eligible to participate in the Company’s long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the reputed company –48 hours per calendar year; for employees who reside in the reputed company –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Company Overview