Engineer II, Design Quality

Job Overview

The Engineer II, Design Quality is an active member of the Design Quality Engineering (DQE) Team who will provide design assurance support for our existing commercially released medical devices, as well as new product development projects. You will be part of a collaborative cross-functional team, often consisting of members from Product Development Engineering, Clinical Affairs, Marketing, Regulatory Affairs, Production and Supplier Quality Engineering, Manufacturing Engineering, and Manufacturing, etc., to support new product development efforts, design changes, supplier changes, manufacturing and process changes, corrective and preventive actions (CAPAs), product complaint investigations, post-market surveillance, risk management activities, and other compliance projects, such as EU MDR uplift of existing products. You will have the opportunity to learn about and work on a variety of medical devices, including chest drains, endovascular stents, and vascular grafts. The main function of the DQE team is to ensure compliance to internal procedures and external regulations, standards, and guidances, and ensure design controls are met throughout the lifecycle of our devices. You will also provide SME input for risk management. You will ensure best practices are followed in documentation and design decisions to support successful audits by regulatory agencies. This role consists mainly of review of product/project documentation and collaborative cross-functional team discussion and decision making.

Job Responsibilities and Essential Duties

• Represent Quality initiatives and compliance when participating on design and development project teams, including in Design and Phase reviews.
• Provide guidance for the generation, review and approval of design control documentation and deliverables
• Evaluate design control documentation (ex. requirements, specifications, FMEAs, verification/validation protocols and reports, etc.) to ensure compliance to external standards and regulations, as well as to internal procedures.
• Assist teams in developing robust user, product, and labeling requirements.
• Ensure that required standards for products are identified and documented in the product requirements specification and assist teams in demonstrating conformance to applicable standards.
• Provide expertise in evaluating design and process changes for impact to existing design control deliverables
• Evaluate equipment documentation, maintenance, and calibration requirements for compliance to external standards and regulations, as well as internal procedures.
• Own risk management activities for device systems in compliance with ISO 14971, including risk management plans/reports, hazard/harm analyses, and FMEAs.
• Ensure the use of statistically valid sampling techniques.
• Support CAPA investigations and implementation of corrective actions.
• Support external audits (ex. scribing, screening documents).
• Remediate legacy products and documentation as required.

Minimum Requirements

• Bachelor's Degree in Engineering or Science, or equivalent work experience.
• A minimum of two years of related experience in medical device or QMS environment.

Required Knowledge, Skills and Abilities

• Thorough knowledge of Quality System Regulations, ISO 13485, ISO 11607, ISO 14971, and other recognized international quality system standards and how they relate to design control, risk management, and other quality practices.
• Experience with statistics, SPC process control and ability to analyze data and interpret results.
• Sufficient analytical and problem solving skills
• High level of attention to detail and accuracy.
• Demonstrated ability to resolve quality-related issues in a timely and effective manner.
• Ability to prioritize and manage key deliverables in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
• Strong project management and prioritization skills are required.
• Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required.

Supervision/Management Of Others:

• None.

Internal and External Contacts/Relationships

• This role will work internally with cross functional team members from engineering, regulatory, marketing, clinical, and manufacturing/quality control functions.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• May work extended hours during peak business cycles.
• May work both onsite and remotely.

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

Annual salary of 80K to 100K with 8% STIP

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