Systems Engineer

Description

The role is a Systems Engineer position based in New Kensington, PA, on the Sleep and Respiratory Care R&D and Systems Engineering team.

The team develops and sustains respiratory ventilators and sleep therapy devices, and the work aims to keep the company's Sleep and Respiratory Care products safe, reliable and high quality.

Responsibilities

• Lead the systems engineering work end to end, turning user and business needs into product requirements, setting the technical approach and system architecture, aligning system design across the relevant products and projects in the segment, assigning derived requirements to subsystems, and defining how the system will be integrated.
• Turn user requirements, including clinical, serviceability, reliability and manufacturability needs, along with regulatory requirements and architecture concepts, into functional requirements. Manage those requirements under the requirement management policies, and make sure they are covered, of good quality and fully implemented.
• Own the technical approach and top-level system design, judge whether candidate technical solutions are feasible, and allocate derived requirements such as functions, interface specifications and design budgets to the affected subsystems. Plan and run system-level design reviews.
• Own system-level defect analysis and fixes during system integration, verification and validation. Support product risk management, regulatory and standards compliance, and country approvals.
• Manage technical risk through detailed risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and define risk control measures.

Requirements

• You have at least 2 years of experience developing complex medical devices with a focus on systems engineering across hardware, software and consumables. Experience with sleep therapy or ventilation products and accessories is strongly preferred.
• You bring test-driven design methods, analytical and architectural thinking, a whole-system view, physical intuition, flexibility, and a hands-on approach to reach durable results and creative solutions.
• You understand the system design process, including model-based (MBSE/V model) design: concept, requirement writing, functional and technical design, checking and optimizing, verification, integration and validation.
• You know medical device quality system rules and standards such as FDA Quality System Regulations, ISO 13485, 14971, 10993, 18562, 17510 (2015) and IEC 62366, and you understand clearance processes.
• You hold a Bachelor's degree, required, in engineering, preferably systems, biomedical, mechanical or a similar field. A Master's degree is preferred.
• You can meet the minimum physical, cognitive and environmental job requirements, with or without accommodation.
• You consistently put patient safety and quality first, and you communicate well in writing and in person, with strong computer, documentation, presentation and interpersonal skills. You can work independently and also across functions and in collaboration with others.

Conditions

The team works together in person. Office-based staff are expected on site at least 3 days per week. Onsite roles require full-time presence at the company's facilities, and field roles are mostly done at customer or supplier sites.

This is an office role.

The pay range for this position in New Kensington, PA is $102,000 to $163,000. Actual base pay may fall anywhere in that range based on job-related knowledge and skills, experience, business needs, location and internal equity. Other pay such as an annual incentive bonus, sales commission or long-term incentives may also be offered. Offers are rarely made at or near the top of the range, and pay decisions depend on the facts of each case.

US work authorization is required. The company will not consider candidates who need sponsorship for a work visa, now or in the future.

The company does not provide relocation benefits for this role. You must live in or within commuting distance of New Kensington, PA.

The posting is expected to stay open for 45 days but may close sooner once a candidate is selected or if business needs change.

The company is an equal opportunity employer that includes disabled people and veterans.

Benefits

• Eligibility for the company Total Rewards program, including generous PTO, a 401(k) with up to a 7% match, an HSA with company contribution, a stock purchase plan, education reimbursement and more.