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Title: Sr. Development Quality Engineer Duration: 12 Months Location: St. Paul, MN 55117 (Hybrid, up to 2 days Remote. Some weeks it will be 100% on-site.) Description: We are seeking an experienced Development Quality Engineer to join our Structural Heart team at our St. Paul, MN location. The individual in this position will support sustainability of commercially released products or new product development. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs 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 on-time 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 cross-functional root-cause 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: Bachelor's degree within an Engineering field or a closely related discipline. 5-8+ 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 cross-functional 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 fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Multitasks, prioritizes, and meets deadlines while delivering high-quality work Strong organizational and follow-up skills, as well as attention to detail. Ability to travel occasionally (<5%), including internationally. Preferred Qualifications: Cardiovascular or other Implantable Medical Device development and/or manufacturing experience strongly preferred. Previous Development Quality Engineering experience. ASQ CQE or other certifications. Other Qualifications: Ability to multitask Previous client's experience nice to have Experience development, design engineering, R&D engineering BG highly preferred Mechanical and Biomedical Engineering degrees preferred, but not required Cross functional communication - working daily with R&D Interview Process: 2 rounds - 1st round video interview with peers, 2nd interview onsite Local candidates only to start SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.