Sr Scientist, Biomaterials R&D

Johnson & Johnson•West Chester, IN

15h•Onsite

About The Position

DePuy Synthes is recruiting a Senior Scientist, Biomaterials R&D, based in Warsaw, Indiana, or West Chester, Pennsylvania. The role supports development of new biomaterials technologies and in-market products throughout their product life cycles. The scientist prototypes and tests innovative materials technologies, develops test methods and manufacturing processes, and supports regulatory submissions. The position provides technical expertise in materials science, chemistry, and test methods to cross-functional teams, and involves communication with R&D scientists and engineers, Marketing and Sales consultants, customers, and health care professionals. The Senior R&D Scientist supports complex medical-device design and development throughout all phases of the product life cycle. As a biomaterials science and chemistry subject matter expert, the scientist plans and oversees technology development, product development, regulatory filings, product launches, and commercialization. Work includes laboratory testing, design verification and validation, scientific experimentation, technical reporting, compliance support, and collaboration with internal functions and suppliers. The role may also involve budget responsibilities and technical or project leadership.

Requirements

At least six years of experience developing or testing biomaterials-based medical devices or combination products.
Master’s degree in Chemistry, Materials Science, Biomedical Engineering, or equivalent.
Depth of knowledge in biomaterial technologies and chemical test methods.
Strong communication skills, including the ability to communicate concepts, ideas, and knowledge to management, colleagues, customers, health care professionals, and teams across the organization.
Ability to work effectively as a technical leader and, at times, as a project leader.
Strong organizational skills to support project-management functions, including scope definition, budgeting, and contingency planning.
Excellent problem-solving, decision-making, and root-cause-analysis skills.
Interpersonal skills that support conflict resolution in technical situations.
Initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities, supported by technical and/or project leadership experience.
Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.

Nice To Haves

PhD degree.
Experience with medical-device regulations, including Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and ISO quality requirements.
Ability to review and critically assess patents and other forms of intellectual property.

Responsibilities

Provide technical expertise to cross-functional teams supporting design and development of complex medical devices and projects throughout the product life cycle.
Serve as a subject matter expert in biomaterials science, chemistry, and chemical test methods.
Organize, plan, execute, and oversee development of biomaterials technologies, including product development, regulatory filings, product launch, and commercialization.
Participate as a technical team member on cross-functional project teams.
Coordinate with engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, and other departments to develop and test technologies and product concepts.
Independently develop testing protocols using laboratory instruments, standard methods, or custom methods.
Perform or coordinate laboratory work safely in analytical, chemical, or biological R&D laboratories.
Develop and execute design verification and validation plans and activities, including test-plan formation and execution to support global regulatory strategy.
Support development of intellectual property for novel designs or technologies.
Collaborate with supply chain, manufacturing engineering, and suppliers to optimize designs for manufacturability and assembly, produce functioning prototypes, and develop production documentation.
Design and execute or coordinate scientific experiments; analyze and present data and conclusions; and write technical reports.
Apply statistical methods to test-method development and verification and validation activities.
Follow the New Product Development process and maintain high-quality design validation and verification activities.
May operate within a budget and provide input on budget allocation and prioritization.
Perform quality and compliance activities supporting audits, remediation projects, non-conformances, and regulatory-compliance projects.
Participate in compliance-program activities as directed by a supervisor or the Chief Compliance Officer.
Communicate business-related issues or opportunities to the next management level.
Follow applicable company Health, Safety, and Environmental practices and comply with relevant laws, regulations, policies, and procedures.
Perform other duties as assigned.

Benefits

Consolidated retirement plan (pension), subject to plan terms.
401(k) savings plan, subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policies and hire date.
Sick time: 40 hours per calendar year, with specified state-based allowances for Colorado and Washington residents.
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.