Sr Development Quality Engineer

Job Title: Sr. Development Quality Engineer

Duration: 12 Months

Location: St. Paul MN 55117

Job Description:

Primary Responsibilities:

Participate in or lead teams in supporting quality disciplines decisions and practices (e.g. represent the Quality function as a Core Team Member).

Lead ontime completion of projects supporting quality and business initiatives.

Support the definition of objective measurable discrete and verifiable customer requirements external requirements and product requirements.

Lead Risk Management activities including analyzing field data to update Risk Management File documents such as Failure Modes and Effects Analysis (FMEA) Hazard Analysis and Risk Management Plan/Report.

Support Test and Inspection Method development including Method Validation activities.

Accountable for Design Verification and Design Validation planning and execution including crossfunctional rootcause investigation and resolution activities.

Support manufacturing process development and qualification for design changes.

Maintain high standards for Device History File (DHF) content completion integrity and regulatory / standards compliance; collaboratively identifying communicating and resolving gaps.

Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.

Lead coach and mentor junior engineers.

Build strong collaborative partnerships with cross functional teams including Program Management Research & Development Regulatory and Process Development to ensure cross functional customer needs are met without creating barriers to development cost time and scope.

Other Responsibilities:

Support preparing Regulatory Submission documentation and responding to questions from Regulatory Agencies.

Additional duties may be identified by functional management based on current project/business objectives.

Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.

Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.

Required Qualifications:

Bachelors degree within an Engineering field or a closely related discipline.

58 years of Medical Device engineering experience and demonstrated use of Quality tools/methodologies.

Familiar with 21 CFR Part 820 ISO 13485 ISO 14971 EUMDR and MDSAP.

Be innovative resourceful and work with minimal direction. Have excellent organization problem solving communication and team leadership skills. Work effectively with crossfunctional teams.

Solid verbal written and interpersonal skills with ability to effectively communicate at multiple levels in the organization.

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fastpaced changing environment.

Ability to leverage and/or engage others to accomplish projects.

Multitasks prioritizes and meets deadlines while delivering highquality work

Strong organizational and followup skills as well as attention to detail.

Ability to travel occasionally (< 5%) including internationally.

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