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Sr. Engineer, Design Quality (Hybrid) - Merrimack, NH

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Date: Dec 2, 2022

Location: Merrimack, NH, US

Company: Getinge

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

 

Job Overview

The Senior Engineer, Design Quality is an active member of the Design Quality Engineering 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 Production and Supplier Quality Engineering, Product Development, Manufacturing Engineering, Clinical Affairs, Marketing, Regulatory Affairs, 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.

 Who You Are:

Someone with a background in medical device manufacturing, 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 FMEA.  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 Functions

  • Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
  • Evaluate equipment documentation, maintenance, and calibration requirements for compliance to external standards and internal standards and procedures
  • Provide verification and validation strategy to product development and process validation teams
  • Provide expertise is risk management and analysis techniques when facilitating completion of FMEAs and risk management files within a cross-functional team
  • Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation
  • 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
  • Author the Quality, Risk and Usability sections of Design Control Quality Plans (DCQP)
  • Represent Quality initiatives and compliance when participating and Design and Phase reviews
  • Participates in 3rd party audits
  • Supports Quality System Software projects
  • Support CAPA and NCR investigations and implementation of corrective actions
  • Remediate legacy products and documentation as required

Required Knowledge, Skills and Abilities: 

  • Excellent analytical and problem solving skill combined with strong technical presence. 
  • Firm understanding of Quality System Regulations, ISO 13485, 11607, 14971, IEC 62304, 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. 
  • Strong project management, prioritization and leadership skills are required.
  • Demonstrated ability to motivate multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Strong computer skills, including MS Office applications (Word, Excel) and statistical software are required.
  • High level of attention to detail and accuracy.

Minimum Requirements:  

  • Bachelors or Master’s Degree in Engineering, or equivalent work experience.
  • A minimum of five years related experience in manufacturing and medical device environment.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.