Product Development Engineer

Johnson & Johnson is a leading company in healthcare innovation focused 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.ResponsibilitiesAssists with the design and development of improvements and modifications to current or new productsWorks with design engineers, marketing, quality, supply chain, Health Care Professionals, manufacturing, regulatory affairs, and other team members to develop functional and design requirements and concepts on new and/or existing productsSupports lead R&D Engineers to develop conceptual models and drawing layouts, prototypes, verification and validation methods and reports, and required Design Control documentationCompletes necessary documentation to support design/development changes; demonstrated proficiency in the application of design controls and development processesAssists with clinician-interactions for purpose of design development, finalization, and clinical evaluation of improvements and modificationsContributes to the development of final design inclusive of manufacturing processes, and inspection processesContributes to the required activities for documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studiesUnderstands and follows the New Product Development process accurately and maintains high quality design validation and verificationsBasic knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment optionsUnderstands the IP process and supports initial patent review of designs for freedom to operateParticipate in complaint investigations and field investigation activities in support of patient/customer safetySupport quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projectsSupport Operations projects associated with Cost Improvement Projects and Production TransfersPerforms other special projects and functions as assignedKnow and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all timesDiligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance OfficerResponsible for communicating business related issues or opportunities to next management levelFor those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicableResponsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresSkillsRecent BS or MS in Mechanical Engineering, Biomedical Engineering, or equivalent requiredProficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.)Ability to work with wet tissues/cadaver and within an Operating RoomGood communication and interaction skills, with the ability to interface with Health Care Professionals and/or teams across the organization"Hands-on" engineerExperience with CAD software (Pro-E, Creo, Solidworks, etc)Experience in the design and development of mechanical products, gained through college co-op, internship or researchExperience with machining of metals or exposure to a machine shop environmentKnowledge of biomechanics, biology, anatomy is a plusKnowledge of medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirementsKnowledge 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 abilityBenefitsEmployees 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 programVacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearCompany OverviewAt Johnson & Johnson, we believe health is everything. It was founded in 1886, and is headquartered in New Brunswick, NJ, US, with a workforce of 10001+ employees. Its website is http://www.jnj.com.Company H1B SponsorshipJohnson & Johnson has a track record of offering H1B sponsorships, with 48 in 2025, 56 in 2024, 58 in 2023, 59 in 2022, 44 in 2021, 27 in 2020. Please note that this does not guarantee sponsorship for this specific role.



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