Engineer, Biomechanical Engineering

Johnson & Johnson•West Chester, PA

About The Position

DePuy Synthes is recruiting an Engineer, Biomechanical Engineering, based 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 cycles. Working within cross-functional project teams, the engineer engages Health Care Professionals and other stakeholders to understand clinical issues and user needs, define design parameters, and ensure products meet functional requirements. The engineer contributes to projects through planning, design, verification and validation, product launch, commercialization, and post-market surveillance. The position includes technical leadership with oversight, design problem-solving, prototyping, design evaluation, regulatory and quality support, and collaboration with manufacturing, supply chain, and suppliers. The engineer also supports product investigations, compliance activities, operations projects, and project management functions while following applicable laws, regulations, and company policies.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
2 to 6 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 types, mechanisms, materials, proper tolerancing, drafting standards, and GD&T.
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, and interpersonal skills that foster conflict resolution in technical situations.
Demonstrated creative design ability and a hands-on engineering approach.
Ability to prioritize tasks and manage a varied workload.
Proficiency with the MS 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

Participate in cross-functional project teams through 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 work closely with the project leader and cross-functional team members.
Engage Health Care Professionals and other 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 such as 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.
Perform activities and prepare documentation to comply with MDR and FDA Design Control regulations and 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 support production documentation.
Apply design controls and development processes, and support project management activities including scope definition and contingency planning.
Maintain knowledge of existing product lines, relevant 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 for audits, remediation projects, non-conformances, and regulatory compliance projects.
Conduct initial patent reviews of designs for freedom to operate.
Support Operations projects, including Cost Improvement Projects and Production Transfers.
Follow applicable laws and policies and maintain professionalism, ethics, and compliance; participate in compliance-program activities as directed.
Communicate business-related issues or opportunities to the next management level.
If supervising or managing staff, ensure subordinates follow applicable Health, Safety, and Environmental practices and have the resources needed to do so.
Ensure personal and company compliance with applicable federal, state, local, and company regulations, policies, and procedures.
Perform other special projects and functions as assigned.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of the plans.
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 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 the birth, adoption, or foster care of a child.
Bereavement Leave: 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.