Hybrid Senior Engineer, Intra-Company Collaborations – MedTech Surgery

at OneTrust

• Job title: Senior Engineer, Intra-Company Collaborations – MedTech Surgery
• Job type: Full Time
• Experience level: Senior
• Salary: $92,000 - $148,350 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Raritan, United States

About the role

• Senior Engineer developing medical devices for Johnson & Johnson's Surgery team. Leading multidisciplinary projects while conducting hands-on lab-based development activities.

Responsibilities

• Lead multidisciplinary project teams in the design, development, testing, and manufacturing of wound closure devices, related products, and other novel medical devices, and be able to function as a team member as required.
• Play a hands-on role in conducting lab-based development activities, analyze and interpret performance and analytical data to guide product and process optimization, document research activities in accordance with design control requirements, and conduct all required research activities associated with development of new materials, components, raw materials, and processes for wound closure devices.
• Effectively apply state-of-the-art scientific technical acumen and technical leadership capabilities to conduct research toward design of new products, as well as supporting and improving (lifecycle management of) existing product offerings.
• Provide technical expertise, in terms of problem solving for technical and executional problems using advanced knowledge and experience.
• Contribute inventions, new designs, new processes, and techniques to solve technical problems based on customer needs.
• Identify opportunities for design and process improvements to achieve business goals.
• Ensure project timelines and all required project milestones are met.
• Conducts or manages research, analysis or processes within a larger R&D activity.
• May develop procedures and processes within broader protocols.
• May develop and implement standards for reporting and operations.
• May identity and implement process level efficiencies.
• Conduct research toward new product or process development or improvement of existing products or processes.
• Interact directly with customers (surgeons) to determine and identify unmet needs.
• Contribute inventions, new designs, new processes and techniques to solve technical problems based on customer needs.
• Uses analytical/technical expertise to contribute to product development/testing.
• Ensures that project guidelines are followed, and processes are complete.
• Executes DOE’s and tests materials per protocols.
• Prepare samples as required for manufacturing, testing, or other evaluations and data analysis.
• Writes SOP’s, JSA’s (Safety) and other required documentation.
• Maintenance of notebooks and batch records in compliance with GLP/GMP
• Participate in process and product transfer to operations group
• May coordinate with outside vendors and academia
• Ensures activities are completed on time and comply with industry standards and regulatory requirements.
• Follows all company guidelines related to Health, Safety and Environmental practices .
• May supervise or provide instruction to professional and technical employees.
• May be responsible for operating within a budget and may provide input on budget allocation and prioritization.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Requirements

• Minimum of a Bachelors Degree is required , Advanced Degree strongly preferred .
• Mechanical Engineering background highly desired .
• At least 5-7+ years of related engineering experience required ( 3-5+ with Advanced Degree ); Medical Device engineering experience strongly preferred .
• CAD (Solidworks or Creo) required , PLM (Windchill) strongly preferred .
• Ability to lead complex projects.
• Effective verbal communication (large and small groups); clear and concise written communication; decision-making without supervisory input; effective team interaction with personnel or other divisions and companies.
• Must deal with abstract and complex “cause and effect” relationships and make sound decisions, often with limited data, which impact product and facilities.
• Knowledge of and experience in applying scientific principles, analytical techniques, and judgment to independently resolve technical issues and establish new methods, controls & procedures is required.
• Knowledge of chemistry and physics, with demonstrated understanding of material characterization, structure-property relationships, formulation development and processing and utilization towards application development is preferred.
• Must be willing to work in a laboratory environment performing hands-on experiments and be able to clearly communicate findings (oral or written) to the project team.
• Broad knowledge of medical device product development and working knowledge of biocompatible materials and their application in medical devices, including familiarity with regulations and requirements for the development of implantable medical devices is preferred.
• Ability to work with minimal supervision.
• Familiarization with material and process specifications.
• Good interpersonal skills, effective oral and written communication skills.
• Proficient using Microsoft Office Software.
• Must be willing to work in a laboratory environment performing hands-on experiments and be able to clearly communicate findings (oral or written) to the project team.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year