Design Quality Engineer (Andover, MA)

Smith+Nephew•Andover, MA

21h•Hybrid

About The Position

Design Quality Engineer (Andover, MA) Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. To maintain the design integrity of Smith & Nephew Medical Ltd. (SNM) wound medical devices. Responsible for ensuring that the safety, performance and quality of new and existing products for SNM conform to established standards and are in compliance with all applicable global Quality System Regulations. What will you be doing? Role holder shall abide at all times to company policies & procedures, and the governing standards & regulations, including (but not limited to): Any Local Hull site or S+N Global Quality System / Health, Safety & Environment Policy, Procedure or Work Instruction contained in the individual’s training plans. Applicable standards as defined in the Quality Manual (including but not limited to): ISO 9001 - ISO 14001 - ISO 13485. Applicable regulations as defined in the Quality Manual (including but not limited to): EU Medical Device Directive / Regulation, Regulations issued by the 5 MDSAP Jurisdictions, UK Human Medicines & Medical Device Regulations, cGMP, cGDP (including 2013/C 343/01), cGLP as applicable for each role. To carry out day-to-day Design Quality activities for all marketed and NPD Advanced Wound Management products. This includes, but is not limited to: Ensuring compliance of design control and design change activities through the review and acceptance of design activities independently of the New Product Development (NPD) design team and/or sustaining engineering teams. Ensuring that Design History Files and other associated quality documentation are complete and compliant by means of review and approval. Work with NPD and/or sustaining engineering teams to ensure verification and validation outputs meet design inputs through the creation-review-execution of test cases and participation in product risk analyses and change reviews. Provide support to Operations and Quality Assurance (QA) teams to ensure successful transfer of the design to manufacturing, in accordance with all applicable regulations. Assist in the adoption of test methods, equipment acquisition for product testing, validations/qualifications, statistical analysis of data for significance and other requirements through review and approval of protocols and reports. Participate in the creation and approval of complete, unambiguous, and measurable design inputs. Review and approve specifications, including those for raw materials, intermediate products and finished products. To carry out day-to-day Risk Management activities for all marketed and NPD Advanced Wound Management products. This includes, but is not limited to: Generating and maintaining elements of the Risk Management File in line with design control and change control requirements. Contributing to Health Hazard Evaluation / Notification to Management processes where required for specific risk matters. To ensure satisfactory and timely completion of all risk control activities. To assist, where appropriate, in the preparation and analysis of information for Safety and Efficacy Review Board, including the identification of potential medical risks. To ensure that user instructions are complete and accurately reflect the product risk through contribution to, and approval of, IFU text. To provide guidance and support to the Advanced Wound Management Division in all areas of product risk management. To establish and sustain compliant and fit for purpose processes and procedures for the development and maintenance of safe, efficacious and high-quality medical devices and associated products. Ensure timely review of current SOPs and WoW. Continuously improve current SOPs and WoW to meet the ongoing needs of the business. To maintain the currency of knowledge required to carry out activities and responsibilities effectively through proactive personal development planning.

Requirements

Bachelor's Degree in a relevant life science / engineering discipline with 2+ years of appropriate experience.
Exposure of the requirements for and application of Risk Management for medical devices in accordance with ISO 14971.
Exposure of the requirements for and application of Design Control for medical devices in accordance with ISO 13485.
Exposure of relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
Experience of working in a regulated environment

Nice To Haves

Experience with medical device software development in accordance with ISO 62304 is preferred.

Responsibilities

Ensuring compliance of design control and design change activities through the review and acceptance of design activities independently of the New Product Development (NPD) design team and/or sustaining engineering teams.
Ensuring that Design History Files and other associated quality documentation are complete and compliant by means of review and approval.
Work with NPD and/or sustaining engineering teams to ensure verification and validation outputs meet design inputs through the creation-review-execution of test cases and participation in product risk analyses and change reviews.
Provide support to Operations and Quality Assurance (QA) teams to ensure successful transfer of the design to manufacturing, in accordance with all applicable regulations.
Assist in the adoption of test methods, equipment acquisition for product testing, validations/qualifications, statistical analysis of data for significance and other requirements through review and approval of protocols and reports.
Participate in the creation and approval of complete, unambiguous, and measurable design inputs.
Review and approve specifications, including those for raw materials, intermediate products and finished products.
Generating and maintaining elements of the Risk Management File in line with design control and change control requirements.
Contributing to Health Hazard Evaluation / Notification to Management processes where required for specific risk matters.
To ensure satisfactory and timely completion of all risk control activities.
To assist, where appropriate, in the preparation and analysis of information for Safety and Efficacy Review Board, including the identification of potential medical risks.
To ensure that user instructions are complete and accurately reflect the product risk through contribution to, and approval of, IFU text.
To provide guidance and support to the Advanced Wound Management Division in all areas of product risk management.
To establish and sustain compliant and fit for purpose processes and procedures for the development and maintenance of safe, efficacious and high-quality medical devices and associated products.
Ensure timely review of current SOPs and WoW.
Continuously improve current SOPs and WoW to meet the ongoing needs of the business.
To maintain the currency of knowledge required to carry out activities and responsibilities effectively through proactive personal development planning.