Sr. Engineer, Design/Software Quality

Job Overview

The Sr. Engineer, Design/Software Quality is an active member of the Design Quality Engineering (DQE) team who will serve a dual role to both provide design assurance support for our existing commercially released or new product development medical devices, as well as provide direction and support to Quality Management System (QMS) software projects.

For the DQE part of the role, you will be part of collaborative cross-functional teams, often consisting of members from Product Development Engineering, Clinical Affairs, Marketing, Regulatory Affairs, Production and Supplier Quality Engineering, Manufacturing Engineering, and Manufacturing, etc. The incumbent will 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, in addition to other compliance and continuous improvement projects. This role consists mainly of review of product/project documentation and collaborative cross-functional team discussion and decision making. You will have the opportunity to learn about and work on a variety of medical devices, manufactured at the Merrimack site.

For the QMS software part of the role, you will be part of collaborative cross-functional teams, often consisting of members from IT and Engineering and/or Manufacturing, to support software needs from implementation of new software to changes to existing software utilized for the QMS. This role will be responsible for ownership of the QMS software processes of the site, identification of bugs, defects, and issues through testing and analysis including maintenance and continuous improvement of the procedures. You will also be responsible for participating on and leading QMS software projects, often providing mentorship and guidance to the software system owners. This role should have technical background in software, infrastructure of applications, and overall guidances/regulations related to software.

This role is to ensure compliance to internal procedures and external regulations, standards/guidances, and ensure design and software controls are met throughout the lifecycle of our medical devices and QMS software. You will ensure best practices are followed in documentation and design decisions to support successful audits by regulatory agencies.

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, QMS software, and other quality practices. You have experience with the product and QMS software development lifecycle, assessment and implementation of design and QMS software 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 and software requirements, performing Design Verification and Validation, performing QMS software IQ/OQ/PQs, performing Test Method Validation, conducting design and code 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 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 and QMS software processes overall. You have the ability to, manage multiple priorities, and work well under pressure and in 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

• Represent Quality and compliance initiatives when participating on design and development or QMS software project teams, including in Design/Phase and Code reviews.
• Provide guidance for the generation, review and approval of design control and QMS software documentation and deliverables.
• Evaluate design control and QMS software 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.
• Provide subject matter and technical expertise in regards to software and software compliance measures to other parts of the organization. Provides assessment of supporting infrastructure for applications.
• Ability to contribute to code reviews and make technical determinations analyzing software change management and testing needs.
• Responsible for maintaining the QMS Software procedures and related forms and templates.
• Assist teams in developing robust device user, product and labeling requirements, as well as QMS software 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/process changes for impact to existing design control deliverables, as well as software changes to existing QMS software documentation.
• 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, etc.).

Minimum Requirements

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

Required Knowledge, Skills and Abilities

• Firm understanding of Quality System Regulations, ISO 13485, ISO 11607, ISO 14971, 21 CFR Part 11 and other recognized international quality system standards and how they relate to design control, risk management, QMS software, and other quality practices.
• Experience with statistics 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/PowerPoint) and statistical software are required.
• Advanced understanding of software testing techniques (e.g. performance, unit, integration, automated), their strengths and weakness, and ability to use them to best effect
• Ability to use software tools (such as build tools, source control, system administration/Unix tools) to assist in reviews.

Internal and External Contacts/Relationships

• This role will work internally with cross functional team members from engineering, regulatory, marketing, clinical, manufacturing/quality control, and IT 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.
• Hybrid role - minimum of 3 days per week on site.

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.

95K-120K annual with 10% STIP

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