Find & Apply For Software Developer / Engineer Jobs in Arden Hills, Minnesota

6+ month contract

Arden Hills, MN Pay:

$60-$70hr Analyzes product performance and post-market surveillance data to develop, maintain, and continuously improve complaint monitoring strategies. Applies statistical concepts, product knowledge, risk-based decision making, and cross-functional collaboration to establish appropriate product complaint trending criteria and document supporting rationale. Partners with quality, clinical, regulatory, manufacturing, and engineering stakeholders to ensure monitoring approaches remain effective, compliant, and aligned with product risk profiles throughout the product lifecycle. Key Responsibilities Leads or supports projects focused on developing, maintaining, and improving product complaint monitoring strategies and criteria. Evaluates complaint data, product risk profiles, lifecycle characteristics, and usage patterns to determine appropriate monitoring methods and thresholds. Develops, documents, and defends the rationale for product-specific trending criteria using statistical principles and engineering judgment. Partners with cross-functional stakeholders including Product Development, Manufacturing, Clinical, Regulatory, Quality, and Complaint Investigation teams to ensure monitoring approaches remain appropriate and effective. Reviews and periodically reassesses existing monitoring strategies to ensure they remain aligned with product performance, risk, and regulatory requirements. Performs complaint trending analyses and investigates potential signals, anomalies, or emerging product performance concerns when identified.

Requirements:

BS Engineering and 7+ years of Medical Device, post-market surveillance, complaint handling, complaint trending or reliability Statistical reasoning and application of basic-to-intermediate statistical methods

• Product complaint trending and signal detection Technical writing and rationale documentation Cross-functional collaboration and stakeholder engagement Problem solving and critical thinking

• Project management and organization Knowledge of FDA post-market surveillance expectations, EU MDR PMS activities, or related quality system requirements. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPB Pay:

$60.00 - $70.00 per hour People with a criminal record are encouraged to apply

Work Location:

In person