Leading a team of R&D Design Development Mechanical engineers and scientists developing products across the Vascular Access Solutions, Assurance & Monitoring Solutions, and Peri-Operative Surgical Solutions portfolios
Minimizing project uncertainty as early as feasible by clearly defining scope and product requirements
Aligning program timing and resources with design capability to best fit within the product portfolio
Identifying new capabilities or capacities to develop internally or acquire externally
Developing component, subassembly, assembly, and product designs that are reliable and manufacturable
Working in concert with IP&SS R&D Product Development to maintain effective extended team resource allocation – to achieve committed deliverables
Identifying, planning, documenting, and executing design controls and risk management processes and procedures
Evaluating product functionality, performance, and safety through characterization, verification, and validation testing
Continuously evaluating selected designs to ensure they meet design input requirements and performance requirements while reducing project-, cost-, and timeline-risk and increasing certainty of business case attainment
Transferring technology design knowledge to Sustaining Engineering as products enter the market; maintaining a role as technical subject matter experts to support Sustaining activities as needed
Ensuring the health and vitality of our IP&SS new product development portfolio and products by defining and implementing vision, culture, and development focus areas for the team and our people

Requirements

Bachelors Degree in an applicable technical field
Ten years of relevant experience
Experience in a regulated industry, medical devices preferred, utilizing design controls to design, develop, verify, validate, and commercialize new products
Previous experience managing people, leading teams, and developing/managing budgets
Expertise in project technical leadership with the ability to oversee multiple projects simultaneously
Experience with and working knowledge of ISO9000, FDA and GMP requirements including product requirements, specification documents, risk management files
Proficiency in MS Office applications (including Word, Excel, PowerPoint), strong written and verbal communication skills, ability to read and understand technical drawings

Benefits

Medical
Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

design controlsrisk managementproduct developmentverification testingvalidation testingproject managementtechnical leadershipdesign documentationcomponent designmanufacturing processes

Soft Skills

team leadershipcommunicationorganizational skillsproblem-solvingcollaborationbudget managementscope definitionresource allocationperformance evaluationtechnical subject matter expertise