Sr Principal Eng, Systems

About the role

In the Senior Principal Engineer, Systems role, you will be responsible for Product Requirements management, Traceability, DHF structure & maintenance, Product Risk management, System integration, verification, and validation of medical devices. This position may own & perform relevant System Engineering activities for a family of devices in Acute therapies. Technically lead the team of system engineers towards realizing product development/enhancements over its lifecycle.

What You'll Be Doing

• Perform the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance
• Gather inputs for Requirements from various sources such as, User needs, Regulatory Standards, Quality, Human factors, Manufacturing, Service, and so on. Perform impact assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service, or manufacturing to determine the impact and need for any mitigation. Develop the recommended mitigation strategy with a rationale.
• Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities
• Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering
• Facilitate an improved understanding of the interrelationship between Requirements, Risk, and Reliability
• Working knowledge of FMEAs and standards applicable to Systems Engineering
• Create design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area
• Understand clinical and user needs and can apply to product realization. Create and maintains Design History File elements.
• Influence stakeholders and cross-functional team members within the project
• Teach and mentor others in life cycle management methodologies
• Initiates, develops and leads technical feasibility analysis for products or subsystems; translates customer/user needs to product needs
• Propose and drive solutions to complex technical problems that are ambiguous and diverse in scope
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
• Anticipate technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results
• Perform as an independent reviewer in technical and design reviews

Required Skills

• A Bachelor's Degree in Electrical, Mechanical, Biomedical, or a related engineering or science discipline
• 12 years or more of relevant experience
• Broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)

Preferred Skills

• Prior experience in Medical/Acute device domain
• Ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product
• A track record in electromechanical system development, preferably in medical devices or other highly regulated products such as military hardware
• Effective communication skills, both verbal and written
• Demonstrated strategic technical planning and thinking with ability to drive architecture/ platform/ technology deliverables into the product roadmap to ensure competitive differentiation

Pay

The estimated base salary for this position is $120,000 to $165,000 annually. This position may also be eligible for discretionary bonuses. Individual pay is based upon location, skills and expertise, experience, and other relevant factors.

Schedule

Minimum of 3 days a week onsite.

Benefits

• Medical, dental and vision coverage starting on day one
• Basic life, accident, short-term and long-term disability, and business travel accident insurance
• 401(k) retirement savings plan (Aon Pooled Employer Plan) with investment options, financial education, and retirement resources
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits