Senior Systems Engineer

The Senior Systems Engineer within the Reprocessing business will be responsible for technical leadership and technical realization of new features or evolving existing features. This person will have the opportunity to work cross functionally with multiple engineering disciplines and will be a technical stakeholder within the system level reviews, while working within the project constraints of schedule, cost, performance, quality, and reliability objectives.

• Drive refinement and translation of stakeholder requirements including safety, clinical application, serviceability, manufacturability, reliability, quality, etc.
• Translate the requirements management policies of the program and review quality of requirements, development of technical approach, top level design, feasibility of potential technical solutions, and allocation of derived requirements, including functionality, interface specifications and design budgets onto affected subsystems.
• Plan, oversee, and execute the Systems Engineering activities in the project, including initiation, coordination, synchronization, review, and integration of the technical work performed within various Engineering disciplines.
• Lead and/or participate in cross-discipline feasibility and tradeoff studies, drive system-level design & technical reviews.
• Lead and/or participate in defect management, risk management, usability activities, preparation of documentation, system integration, verification, and validation.
• Collaborate with Project Management to provide Systems related tasks and timelines.
• Lead and/or assist in developing system architectural platform roadmaps and technology roadmaps and ensuring key software and component decisions align.
• Support establishing functional excellence rigor through best practice guidelines, technical reviews, design reviews and LEAN continuous improvement.
• Work cross-functionally to ensure that products meet user needs and that all regulatory and compliance requirements are met.
• Leads system integration (follow up, analysis, problem solving), verification and validation.
• Defines testing requirements and strategy and drives formal verification & validation
• Harmonizes common features, system functions and improvement solutions across relevant products.

Required:

• A Bachelor's degree in a relevant discipline is required
• A minimum of 5 years of progressive experience in systems engineering.
• 5+ years of involvement in a multi-disciplined project development environment.
• 5+ years of engineering experience in one area with a deep understanding in a second area (such as software, electrical engineering, or mechanical engineering).
• 5+ years of experience in requirement management and risk analysis. 5+ years of experience in medical device product development.

Skills:

• Previous experience working with regulatory authorities and standards such as ASME, CRN, PED, UL, ISO, MDR, CE, or FDA.
• Demonstrated advanced systems thinking skills.
• Proven ability to lead the evolution of complex systems, requiring evaluation of multiple candidate solutions and significant evaluation of intangibles.
• Ability to participate in or lead technical analysis, including the evaluation of multiple reward solutions.
• Capability to propose and develop methods, techniques, and evaluation criteria to realize product functionality.
• Proven excellence in technical leadership within a matrix environment, including the ability to influence indirect resources.
• Excellent communication, influencing, and conflict resolution skills.
• Strong technical writing and presentation skills.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

Here is a brief overview of what we offer:

• Market Competitive Pay
• Extensive Paid Time Off and (9) added Holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term Disability Coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued education programs
• Excellent opportunities for advancement in a stable long-term career.