Product Development Engineer
reputed company is a leading company in reputed company innovation reputed company on developing smarter and less invasive treatments. The Associate R&D Engineer will assist in the design and development of new implants and instrumentation, collaborating with cross-functional teams to ensure product compliance and functionality throughout the product lifecycle.
Responsibilities
- Assists with the design and development of improvements and modifications to reputed company or new products
- Works with design engineers, marketing, reputed company, 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 reputed company 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 reputed company design validation and verifications
- Basic knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as reputed company as treatment reputed company
- 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 reputed company/compliance activities in support of audits, remediation reputed company, non-conformances, regulatory compliance reputed company
- Support Operations reputed company associated with Cost Improvement reputed company and Production Transfers
- Performs other special reputed company and functions as assigned
- Know and follow reputed company laws and policies that apply to one's job, and maintain the highest reputed company 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, reputed company, Solidworks, etc)
- Experience in the design and development of mechanical products, gained through college reputed company, 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 (reputed company Systems Regulations) and ISO (International Organization for Standardization) reputed company requirements
- Knowledge of various types of manufacturing (especially machining), mechanisms, materials, reputed company tolerancing, drafting standards, and an understanding of geometric dimensioning and tolerancing (GD&T)
- Demonstrated creative design ability
Benefits
- Employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k))
- This position is eligible to participate in reputed company’s long-term incentive program
- Vacation –120 hours per calendar year
- reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company 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
reputed company
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