Principal Engineer, Design Quality

Job Overview

The Principal Engineer, 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/Sustaining Engineering, Clinical Affairs, Regulatory Affairs, Marketing, Production and Supplier Quality Engineering, Manufacturing Engineering, and Manufacturing, etc., to support new product development efforts, design changes, risk management activities, supplier changes, manufacturing and process changes, corrective and preventive actions (CAPAs), product complaint investigations, post-market surveillance, 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.

Who You Are:

Someone with a background in medical devices, with strong knowledge of ISO 13485 and 21 CFR 820 and how they relate to design control, risk management, and other quality practices. You have experience with the product development lifecycle, assessment and implementation of design changes, and maintaining compliance to external standards and regulations. You also have working knowledge of ISO 14971 and experience with risk management tools such as FMEAs. You are familiar with creating design inputs, performing design verification and validation, performing process and test method validation, conducting design reviews, and supporting design transfer to manufacturing. You have familiarity with statistical analysis techniques and sampling plans. You have strong technical writing skills, experience in root cause analysis, and you have extreme attention to detail but also have the ability to see the "big picture" i.e. how each part of a project feeds into the design control process overall. You have the ability to learn quickly, manage multiple priorities, and work well under pressure and a fast-paced environment. You are an individual that is self-driven, possesses a strong desire to learn, strives for excellence, and always keeps quality and the customer in mind in everything you do.

Job Responsibilities and Essential Duties

• Supervise/manage junior Design Quality Engineers, including selecting, training, scheduling, monitoring, and evaluating staff.
• Lead quality initiatives and compliance when participating on design and development project teams, including in Design and Phase reviews.
• Own risk management activities for device systems in compliance with ISO 14971, including risk management plans/reports, hazard/harm analyses, and FMEAs.
• Lead continuous improvement efforts related to design controls, risk management and other quality functions.
• 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.
• Ensure the use of statistically valid sampling techniques; Teaches others on the use of these and other advanced statistical techniques such as DOE and ANOVA.
• Participates in and represents the Design Quality Engineering function during audits by 3rd parties.
• Support CAPA investigations and implementation of corrective actions.
• Remediate legacy products and documentation as required.

Minimum Requirements

• Bachelor's Degree in Engineering or Science, or equivalent work experience.
• A minimum of eight years of related experience in quality assurance, quality engineering, or related functions.

Required Knowledge, Skills and Abilities

• Firm understanding 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 is preferred.
• Excellent analytical and problem-solving skills combined with strong technical presence.
• High level of attention to detail and accuracy.
• Demonstrated ability to motivate multi-departmental project teams and 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, prioritization and leadership skills are required.
• Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required.

Supervision/Management Of Others:

• This position includes mentoring and/or supervision/management of up to two junior Design Quality Engineers.

Internal and External Contacts/Relationships

• Internal: Cross functional teams, including but not limited to: R&D, ME, Regulatory, Clinical, Marketing, PMO
• External: Regulatory bodies (ex: FDA, TUV)

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 115K to 140K with 15% STIP

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