Engineer Biomechanical Engineering

Johnson & Johnson Innovative Medicine•West Chester, PA

11d•$76,000 - $121,900•Onsite

About The Position

DePuy Synthes is recruiting an Engineer, Biomechanical Engineering for its West Chester, Pennsylvania location. The role helps lead the design and development of new implants and instrumentation and supports in-market products throughout their life cycle as part of cross-functional project teams. It involves working with Health Care Professionals and marketing to understand clinical issues, define design parameters, and ensure products meet functional requirements. The engineer contributes to projects from planning and development through product launch, commercialization, and post-market surveillance. The role applies CAD, prototyping, GD&T, design evaluation, and verification and validation methods; supports regulatory and quality processes; and collaborates with manufacturing, supply chain, and suppliers on manufacturability and production documentation. It also supports complaint and field investigations, operational improvement and transfer projects, and patent reviews. The position requires compliance with applicable laws, company policies, quality requirements, and professional and ethical standards.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
At least 2 years of experience designing and developing medical devices, mechanical products, or biomechanical systems.
Experience with CAD software such as Pro-E, Creo, or SolidWorks.
Understanding of manufacturing types, mechanisms, materials, proper 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 work with Health Care Professionals and sales and marketing personnel.
Strong problem-solving, decision-making, and root-cause analysis skills, as well as interpersonal skills to resolve technical conflicts.
Demonstrated creative design ability and a hands-on engineering approach.
Ability to prioritize tasks and manage a varied workload.
Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
Ability to work with wet tissues or cadavers and in an Operating Room setting.
Compliance with applicable laws, company policies, and professional and ethical standards.

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.
Skills and experience listed in the posting include bioinformatics, biological engineering, biological sciences, biostatistics, data reporting, data savvy, design of experiments, detail orientation, execution focus, feasibility studies, preclinical research, problem solving, process orientation, prototyping, report writing, research and development, researching, SAP Product Lifecycle Management, and technological savvy.

Responsibilities

Design and develop new implants and instrumentation and support in-market products throughout their product life cycle.
Participate in cross-functional project teams across product life-cycle phases, assisting the project leader with planning and execution through launch, commercialization, and post-market surveillance.
Technically lead design and development projects with oversight and collaborate with project leaders and core team members across marketing, manufacturing, quality, testing, supply chain, and regulatory functions.
Engage Health Care Professionals and functional 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; support global product registration efforts.
Prepare required activities and documentation for compliance with MDR and FDA Design Control regulations and to support 510(k) submissions or IDE clinical studies.
Collaborate with supply chain, manufacturing engineering, and suppliers to optimize designs for manufacturability and assembly, produce functioning prototypes, and prepare production documentation.
Apply design controls and development processes, and support project management activities such as scope definition and contingency planning.
Maintain knowledge of product lines, applicable anatomic injuries and pathologies, and treatment options; follow the New Product Development process.
Perform complaint investigations and field investigations in support of patient and customer safety.
Support or perform quality and compliance activities, including audits, remediation projects, non-conformances, and regulatory compliance projects.
Conduct initial patent reviews of designs for freedom to operate.
Support Operations projects involving cost improvement and production transfers.
Perform other assigned projects and functions.
Follow applicable laws and policies and maintain professional, ethical, and compliance standards; participate in compliance program activities as directed.
Communicate business issues or opportunities to the next management level.
Where applicable, ensure supervised staff follow Company Health, Safety, and Environmental guidelines and have the resources needed to do so.
Ensure personal and Company compliance with applicable federal, state, local, and Company regulations, policies, and procedures.

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 date-of-hire terms.
Sick time: 40 hours per calendar year, with stated state-specific amounts for Colorado and Washington employees.
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.