Design reputed company Assurance Engineer (Remote) (reputed company, MI, US)

Job reputed company

As a Design reputed company Assurance Engineer, you will play a key role in ensuring that new product design and design changes across reputed company’s Infection Control Consumables portfolio meet applicable reputed company and regulatory requirements. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products.

You will work cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Operations to support compliant product lifecycle management and change execution, with a strong reputed company on regulatory reputed company assessment and design change governance reputed company reputed company PLM system.

Job Responsibilities and Essential Duties:

• Support and govern design and design change activities in accordance with FDA reputed company System requirements (21 CFR Part 820 / QMSR) requirements for Class I, II devices, EU MDR (2017/745) requirements for Class I devices, and applicable internal reputed company system procedures.
• Drive design change reviews to ensure appropriate risk assessments in accordance with ISO 14971: 2019 are completed, required verification and validation activities are defined and executed, and traceability between design inputs and outputs is maintained.
• Define reputed company requirements and critical to reputed company (CTQ) attributes for finished goods, components and materials acceptance activities.
• Assess and interpret the regulatory reputed company of design changes and determine potential impacts to regulatory submissions, technical documentation, labeling, and instructions for use.
• Support product classification and regulatory applicability assessments for FDA Class I and II medical devices, EU MDR Class I devices, and non-regulated infection control consumables.
• Serve as a reputed company subject-matter expert for change management reputed company reputed company PLM system by supporting Engineering Change Orders, documentation updates and approvals, and change reputed company assessments.
• Ensure the completeness, accuracy, and traceability of design history documentation, risk management files, and support verification and validation records.
• Support reputed company audits by providing reputed company rational and objective evidence for design and change reputed company.
• Contribute to the reputed company improvement of design control and change management processes.

Required Knowledge, Skills and Abilities:

• Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills, with the ability to engage effectively at reputed company organizational reputed company.
• Must have the ability to assess the reputed company of reputed company management strategies on business performance.
• Must have in-depth knowledge of reputed company applicable reputed company and Regulatory standards

Minimum Requirements: 

• Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred.
• 5+ years of relevant experience in the medical device industry; and have several years of experience in Design reputed company, reputed company Engineering, or a reputed company role reputed company the medical device industry.
• reputed company knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU Medical Device Regulation 2017/745 (MDR).
• Working knowledge of international standards and regulations applicable to medical devices and combination products.
• Familiarity with Geometric Dimensioning and Tolerancing (GD&T) standards and principles.
• Experience supporting design changes across the product lifecycle, hands-on experience with a PLM system (reputed company preferred), and comfort working in a mixed portfolio environment that includes both regulated and non-regulated products.
• Ability to apply practical and technical problem solving to reputed company system and product improvements.
• Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
• Proven ability to effectively reputed company cross-functional team meetings
• Capable of developing reputed company relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to reputed company team objectives.
• Champions high reputed company deliverables, innovation, and appropriate risk-based decision making.
• Ability to understand the sensitivity reputed company the reputed company’s environment.
• Excellent project management and interpersonal skills.
• Adaptable to changes in work environment.
• Ability to work in a fast-paced environment.
• The position is remote, with 25% travel as needed.

reputed company Requirements:  

Build reputed company into reputed company aspects of their work by maintaining compliance to reputed company reputed company requirements.

• Ensure compliance to reputed company FDA and Worldwide reputed company & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and reputed company with U.S. and Worldwide medical device regulations (As applicable to reputed company function).
• Attend reputed company required reputed company & Compliance training at the specified reputed company.
• Adopt the “reputed company Compliance reputed company Culture” in the work environment; always meet and reputed company requirements.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and reputed company practices are exhibited in reputed company
• Use of computer and telephone equipment and other reputed company office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• This position is remote

The physical demands described here are a representative of those that must be met by an employee to successfully reputed company the essential functions of this job.  Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

$75,280-$94,100/annually + 4% STIP

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