Key skills are risk management and change control experience in medical devices, with electronics or electrical engineering backgrounds preferred.
This role is to support post-market risk response (health-risk assessment, PHO, etc.) and risk management remediation for Affera Hardware products. Ideal candidates will have risk management and post-market experience with capital equipment medical devices.
The role will be focused on post-market risk response, which is risk assessment process including HRA and potential PHO or FCA initiation l, as well as remediation of our risk management files. The files were written by Affera prior to acquisition, and we now need to make updates to hazards and hazardous situations to align with CAS procedures. This will involve meeting, investigation, conformance assessment, risk assessment, application of issue evaluation and HRA procedures with deliverables drafting, leading review, finalization and release in compliance with required timing. Will also involve risk file reclining, meeting with med safety, other team members and cross functional partners to resolve gaps in the files to meet CAS procedures. Change orders l and CAPA support activity, as well as lab testing for investigations, dv test and or tmv may also be assigned.
Responsibilities may include the following and other duties may be assigned. 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 for achieving required levels of product reliability. Completes risk analysis studies of new design and processes, as well as design changes and emerging issues/escapes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
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TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent assessing and executing compliance processes for risk management and risk reponse for commercial therapies – from design to implementation – while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of 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 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 in order to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master’s degree
