Sr. Engineer, Design Quality

Getinge•Merrimack, NH

7d•Hybrid

About The Position

The Sr. 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 Engineering, Clinical Affairs, Marketing, Regulatory Affairs, 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.

Requirements

Bachelor’s Degree in Engineering or Science, or equivalent work experience.
A minimum of five years of related experience in medical device environment.
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.
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.

Nice To Haves

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.
Experience with the product development lifecycle, assessment and implementation of design changes, and maintaining compliance to external standards and regulations.
Working knowledge of ISO 14971 and experience with risk management tools such as FMEA.
Familiarity with creating design inputs, performing Design Verification and Validation, performing Process and Test Method Validation, conducting design reviews, and supporting design transfer to manufacturing.
Familiarity with statistical analysis techniques and sampling plans.
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.
Ability to learn quickly, manage multiple priorities, and work well under pressure and a fast-paced environment.
Self-driven, possesses a strong desire to learn, strives for excellence, and always keeps quality and the customer in mind in everything you do.

Responsibilities

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; Teaches others on the use of these and other advanced statistical techniques such as DOE and ANOVA.
Support CAPA investigations and implementation of corrective actions.
Support external audits (ex. scribing, screening documents).
Remediate legacy products and documentation as required.