Engineer, Biomechanical Engineering

Johnson & Johnson Innovative Medicine•West Chester, PA

7d•$78,000 - $126,500

About The Position

DePuy Synthes, part of Johnson & Johnson, is recruiting a Biomechanical Engineering Engineer for its Orthopaedics business in West Chester, Pennsylvania. The role helps lead the design and development of new implants and instrumentation and supports in-market products throughout their product life cycle. Working on cross-functional project teams, the engineer engages health care professionals and marketing partners to understand clinical issues, define user needs and design inputs, and ensure products meet functional requirements. The engineer contributes to projects from planning and development through launch, commercialization, and post-market surveillance. The position includes solving design problems, evaluating designs, developing and executing verification and validation activities, supporting regulatory submissions and compliance, and collaborating with manufacturing, supply chain, and suppliers to create manufacturable designs and production documentation. It also supports product investigations, quality activities, cost improvement and production transfer projects, and initial patent reviews. The role requires a bachelor’s degree in mechanical engineering, biomedical engineering, or an equivalent field, and 2–6 years of relevant design and development experience. A master’s degree and experience with medical-device regulations are preferred. The position requires CAD experience, knowledge of manufacturing and engineering design practices, strong communication and problem-solving skills, and the ability to work with wet tissue or cadavers and in an operating-room setting. The anticipated base pay range is $78,000–$126,500. Benefits described include retirement and savings plans, long-term incentives, vacation, sick time, holidays, parental, bereavement, caregiver, volunteer, and military-spouse leave.

Requirements

Bachelor’s degree in mechanical engineering, biomedical engineering, or equivalent.
2–6 years of experience in design and development of medical devices, mechanical products, or biomechanical systems.
Experience with CAD software such as Pro-E, Creo, or Solidworks.
Understanding of manufacturing types, mechanisms, materials, tolerancing, drafting standards, and GD&T.
Demonstrated success bringing a product from design through introduction on time.
Strong communication and interaction skills, including the ability to interface with health care professionals and sales and marketing personnel.
Strong problem-solving, decision-making, and root-cause analysis skills, along with interpersonal skills that support conflict resolution in technical situations.
Demonstrated creative design ability and hands-on engineering capability.
Ability to prioritize tasks and manage a varied workload.
Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
Ability to work with wet tissues or cadavers and within an operating-room setting.

Nice To Haves

Master’s degree.
Experience with medical-device regulations, including GMP, QSR, and ISO quality requirements.
Prior project management experience.
Ability to review and critically assess patents and other forms of intellectual property.

Responsibilities

Contribute to design and development of new implants and instrumentation and support in-market products throughout their product life cycle.
Participate in cross-functional project teams through product life-cycle phases, assisting with planning and execution through launch, commercialization, and post-market surveillance.
Technically lead design and development projects with oversight and collaborate with the project leader and cross-functional team members.
Engage health care professionals and other departments to define user needs and design inputs.
Solve design problems using CAD, rapid and conventional prototyping, and other available technologies.
Develop layouts and tolerance studies using GD&T and participate in design evaluations, including FEA, simulated-use testing, dry labs, and wet-tissue or cadaver labs.
Develop and execute design verification and validation plans, test methods, and protocols, and support global regulatory registration efforts.
Generate required documentation and activities for compliance with MDR and FDA Design Control regulations and to support 510(k) submissions or IDE clinical studies.
Work with supply chain, manufacturing engineering, and suppliers to optimize designs for manufacturability and assembly and produce prototypes and production documentation.
Apply design controls and development processes and support project management functions such as scope definition and contingency planning.
Maintain knowledge of product lines, relevant anatomical injuries and pathologies, and treatment options; follow the New Product Development process.
Conduct complaint investigations and field investigations in support of patient and customer safety.
Support or perform quality and compliance activities, including audits, remediation, non-conformances, and regulatory compliance projects.
Perform initial patent reviews of designs for freedom to operate.
Support operations projects involving cost improvement and production transfers.
Follow applicable laws, company policies, compliance requirements, and professional and ethical standards; communicate business issues or opportunities to the next management level.
Where applicable, ensure staff follow company Health, Safety, and Environmental practices and have the resources needed to do so.
Perform other special projects and functions as assigned.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and hire-date terms.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and hire-date terms.
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 within one year of a child’s birth, adoption, or foster care placement.
Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a 52-week rolling period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.
Long-term incentive program.