Lead development activities within a cross-functional program team
Create the technical content, performance, intellectual property and quality results of a combination product development program
Understand and captures the user needs into system requirements
Responsible for the functional decomposition and allocation to subsystems
Ensure that the quality targets are satisfied
Identify technical risks and coordinate risk retirement activities on the program
Maintain close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality
Develop, implement, and review requirements, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects
Create and implement to project plans and schedules
Create and assess product requirements to determine technical coverage and proper integration of different subsystems of combination products
Requirements
Master’s degree
Bachelor’s degree and 2 years of engineering experience
Associate’s degree and 6 years of engineering experience
High school diploma / GED and 8 years of engineering experience
4+ years of progressive experience as an engineer or scientist within the appropriate field of study
2+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination)
Formal Systems Engineering training/certification
Demonstrated applied lean 6 Sigma competency
Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
product developmentsystem requirementsfunctional decompositionrisk managementverification and validationdesign documentsspecificationsdevelopment planscharacterization planintegration
Soft skills
leadershipcustomer satisfactioncreative problem solvingsolution developmentcommunication
Certifications
Master’s degreeBachelor’s degreeAssociate’s degreehigh school diploma / GEDFormal Systems Engineering training/certificationlean 6 Sigma competency