Engineer Biomechanical Engineering

Johnson & Johnson•West Chester, PA

9d•Onsite

About The Position

DePuy Synthes, part of Johnson & Johnson’s Orthopaedics business, is seeking an Engineer, Biomechanical Engineering in West Chester, Pennsylvania. The role helps lead the design and development of new implants and instrumentation and supports in-market products throughout their life cycle. Working on cross-functional project teams, the engineer engages with health care professionals and other stakeholders to understand clinical issues, define user needs and design inputs, and ensure products meet functional requirements. The engineer contributes to projects from planning and design through product launch, commercialization, and post-market surveillance. The role includes technical design work, prototype development, design evaluations, verification and validation, regulatory support, production documentation, complaint investigations, and quality and compliance activities. The engineer also supports manufacturing and supply-chain efforts to improve manufacturability and assembly, as well as operations projects such as cost improvements and production transfers.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
At least 2 years of experience in the 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 methods, mechanisms, materials, tolerancing, drafting standards, and GD&T.
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, with interpersonal skills that support resolving technical conflicts.
Demonstrated creative design ability and hands-on engineering capability.
Ability to prioritize tasks and manage a varied workload.
Proficiency with Microsoft Office applications such as Word, Excel, and PowerPoint.
Ability to work with wet tissue or cadavers and in an operating-room setting.
Demonstrated success bringing a product from design through introduction on time.

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

Participate in cross-functional project teams throughout all phases of the product life cycle, 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, and dry, wet-tissue, or cadaver labs.
Develop and execute design verification and validation plans, test methods, and protocols, and support global regulatory registration efforts.
Perform activities and prepare documentation to comply with MDR and FDA Design Control regulations and support 510(k) submissions or IDE clinical studies.
Work 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 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.
Perform complaint investigations and field investigations to support 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.
Follow applicable laws and company policies, maintain professional and ethical standards, and participate in compliance-program activities as directed.
Communicate business issues or opportunities to the next management level.
When applicable, ensure supervised staff follow company Health, Safety, and Environmental practices and have the resources needed to do so.
Ensure personal and company compliance with applicable federal, state, and local regulations, policies, and procedures.
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 long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
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 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.