Reliability Engineer II - Exempt

This role is focused on supporting post-market risk response and risk management remediation for Affera Hardware products. Ideal candidates will have experience in risk management and post-market processes with capital equipment medical devices.

The role is based in Mounds View, MN, a vibrant community offering a blend of suburban tranquility and proximity to urban amenities, making it an attractive location for professionals seeking a balanced lifestyle.

The primary focus will be on post-market risk response, including risk assessment processes such as Health-Risk Assessment (HRA) and potential Product Hold Order (PHO) or Field Corrective Action (FCA) initiation. The role also involves updating and aligning risk management files with CAS procedures, initially drafted by Affera. Responsibilities include conducting meetings, investigations, conformance assessments, and risk assessments, as well as drafting deliverables, leading reviews, and ensuring compliance with required timelines.

Additional duties may include:

• Reclining risk files and collaborating with medical safety, team members, and cross-functional partners to resolve gaps in the files.
• Supporting change orders and Corrective and Preventive Actions (CAPA), as well as conducting lab testing for investigations, development tests, and/or test method validations (TMV).

The team consists of 8 members, with 6 based in Mounds View, MN, and 2 in Newton, MA. The team includes senior principal, principal, senior, and entry-level engineers.

Key skills required include risk management and change control experience in medical devices, with a preference for candidates with electronics or electrical engineering backgrounds.

Responsibilities

• Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Recommends design or test methods and statistical process control procedures to achieve required levels of product reliability.
• Completes risk analysis studies of new designs and processes, as well as design changes and emerging issues.
• Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting products and processes.
• Ensures that corrective measures meet acceptable reliability standards.
• Analyzes preliminary plans and develops reliability engineering programs to meet company, customer, and governmental agency reliability objectives.
• May develop mathematical models to identify units, batches, or processes posing excessive failure risks.
• Proposes changes in design or formulation to improve system and/or process reliability as necessary.
• Determines units and/or batches requiring environmental testing and specifies the minimum number of samples for statistically valid data.

This position is part of the Technical Specialist Career Stream, where the individual contributor is responsible for advancing existing technology or introducing new technology and therapies. The role involves managing assigned projects and collaborating with other stakeholders to achieve desired results. The majority of time is spent assessing and executing compliance processes for risk management and risk response for commercial therapies, from design to implementation, while adhering to policies using specialized knowledge and skills.

Differentiating Factors

• Autonomy: An established and productive individual contributor who works independently with general supervision on larger, moderately complex projects and assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones and may have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of the job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience

Requires a Baccalaureate degree and a minimum of 2 years of relevant experience, or a Master's degree with a minimum of 0 years of relevant experience.

The interview plan includes interviews with the hiring manager and 1-2 other team members. Video interviews are acceptable, but on-site interviews can be coordinated if preferred by the candidate. The interview process typically involves STAR-format questions around business acumen, technical competency in electrical principles and engineering, deliverables/processes, and experience in quality, change management, and risk management processes.