Senior Development Engineer, Combination Products, Interventional Oncology
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • New Jersey • United States
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Salary
💰 $109,000 - $174,800 per year
Job Level
About the role
- Lead technical product design & development of devices and combination products through clinical trial readiness, including identification of specifications, requirements management, risk management, testing and evaluation, and generating evidence to support regulatory submissions
- Guide external partnerships to deliver collaborative outcomes aligned with program objectives, including partner identification and scoping, establishing clear communication pathways, and overseeing deliverables.
- Engage appropriate team members, including internal subject matter experts, and external academic and industry partners, to address technical challenges and risks
- Develop and update design documentation including, engineering drawings, test protocols, reports, and engineering rationales to support both quality and regulatory documentation under design control processes
- Maintain strong connections with J&J colleagues across medical devices and pharmaceutical sectors as well as J&J Legal, Finance, Regulatory, Clinical, Quality and other functional groups to support, review, and execute product development projects
- Build external relationships via trade shows, conferences, networking, and other new sources of information, intelligence, and insights
- Build knowledge of targeted disease states (e.g., head & neck cancer, non-small cell lung cancer, and other solid organs), standards of care, and procedural approaches through direct observation and primary and secondary research
Requirements
- A Bachelor’s degree in engineering is required
- Five or more years of professional experience in the medical device industry with at least three years focused on drug-led combination products is required.
- Experience in new product development & product design following design controls is required (full product development lifecycle experience highly preferred)
- Combination product development experience from discovery through clinical trials is required, with commercialization/post-launch experience preferred.
- Demonstrated track record of teamwork, collaboration, inclusion, and developing strong business relationships with multi-functional teams is required
- Experience leading through influence and working in a highly matrixed environment is preferred
- Experience with domestic and international multi-site collaboration is preferred
- Ability to travel domestically and/or internationally up to 20% of the time is required
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
product designrequirements managementrisk managementtesting and evaluationdesign controlsengineering drawingstest protocolsregulatory submissionsnew product developmentcombination product development
Soft Skills
teamworkcollaborationinclusionbusiness relationshipsleading through influencecommunicationproblem-solvingnetworkingrelationship buildingcross-functional collaboration
Certifications
Bachelor’s degree in engineering