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Sr. Development Quality Engineer

ICONMA, LLC

Westford, MA

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JOB DETAILS
SALARY
$40.04–$43.15 Per Hour
SKILLS
Agile Programming Methodologies, American Society for Quality (ASQ), Atlassian JIRA, Biomedical Engineering, Business Model, C Programming Language, Change Management, Change Requests/Orders, Code Reviews, Code of Federal Regulations, Communication Skills, Computer Firmware, Computer Science, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Satisfaction, Design Verification, Detail Oriented, Document Management, Documentation Standards, Environmental Management Systems, Establish Priorities, External Audit, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), Follow Through, GMP (Good Manufacturing Practices), Health Plan, Healthcare, Healthcare Quality, Hospital, Human Factors, ISO (International Organization for Standardization), ISTQB Foundation, Implants, Internal Audit, International Electro-Technical Commission (IEC), Internet Security, Java, Leadership, Maintain Compliance, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Medical Products, Microsoft C# (C Sharp), Microsoft Visual Studio, Multitasking, Operations Processes, Organizational Skills, Patient Safety, Perl Programming Language, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Manufacturing, Product Design, Product Development, Product Lifecycle, Product Support, Product/Service Launch, Python Programming/Scripting Language, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Root Cause Analysis, Ruby, Safety Compliance, Scripting (Scripting Languages), Scrum Project Management and Software Development, Software Configuration Management, Software Design, Software Development Lifecycle (SDLC), Software Engineering, Software Testing, Standard Operating Procedures (SOP), Standards Development, Static Analysis, Statistics, Sterilization, Team Player, Technical Support, Technical/Engineering Design, Test Plan/Schedule, Test Tools, Testing, Time Management, Usability Engineering, Validation Plan, Validation Testing, Vendor/Supplier Planning, Writing Skills
LOCATION
Westford, MA
POSTED
6 days ago
Our client, a Medical Device and Healthcare company, is looking for a Sr. Development Quality Engineer for their Westford, MA location.
 
Responsibilities:
  • The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team.
  • Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.
  • Lead and/or support on-time completion of Design Control deliverables
  • Support the establishment of objective, measurable, and verifiable product requirements
  • Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
  • Lead Risk Management activities from product concept through commercialization
  • Support test method development and lead test method validation activities
  • Support manufacturing process development & qualification for new product and design changes
  • Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support biocompatibility and sterilization qualifications
  • Support audits and quality system improvement activities
  • Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
  • Comply with client, U.S. FDA, EUMDR and other requirements, as applicable.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
  • Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA)
  • Support on-time execution of Quality Plans
  • Guide development and documentation of standard operating procedures, specifications and test procedures
  • Support product recertifications
  • CAPA management – including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
  • Work within Agile software development lifecycle framework
  • Support usability and human factors engineering reviews
  • Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
  • Review and approve test methods, protocols and test results provided by another functional group.
  • Support activities related to software change management and overall change management
  • Support all activities, as needed by the business within the software development lifecycle.
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support internal & external audit and related responses
  • Support the establishment of objective, measurable and verifiable customer and product requirements
  • Complete document Change Request reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Perform other related duties and responsibilities, on occasion, as assigned.
  • The Sr. Development Quality Engineer serves as a technical quality representative supporting product development teams.
  • This role provides design quality expertise across the product lifecycle to ensure patient and user safety, regulatory compliance, and customer satisfaction.
  • The position partners closely with cross functional stakeholders to deliver compliant, high quality medical devices from concept through commercialization.
  • Lead or support timely completion of design control documentation
  • Collaborate with cross-functional teams to establish clear, measurable, and verifiable product requirements
  • Support design verification and validation planning, execution, and issue resolution activities
  • Lead risk management activities from product concept through commercialization
  • Support test method development and lead test method validation efforts
  • Collaborate with manufacturing on process development and qualification for new or updated designs
  • Support component specification development, supplier sampling plans, and vendor qualification activities
  • Support biocompatibility and sterilization qualifications
  • Participate in audits and continuous quality system improvement initiatives
  • Ensure compliance with client quality systems, FDA, EU MDR, and other applicable regulatory requirements
  • Maintain effective communication with employees, suppliers, contractors, and customers
 
Requirements
  • Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
  • Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality
  • Experience ensuring automation frameworks and scripts meet design control requirements
  • Experience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama
  • Experience as team-member/lead in Agile SDLC projects/programs
  • Deep knowledge of various types of SDLC’s (V-Model, Iterative, Agile/Scrum, etc.)
  • Experience working in a broader enterprise/cross-site business unit model
  • Working knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to work in a lab, and hands-on experience with medical device development
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Ability to multitask, prioritize and meet deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Master’s level degree preferred
  • ASQ CSQE and ISTQB certifications desired
  • Experience working with test management tools such TestComplete, desired
  • Experience in code review/static analysis tool(s) to aide code review such as Coverity, desired
  • Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired
  • Clinical/Hospital experience desired
  • Experience in software testing and verification/validation, desired
  • Bachelor’s degree in Engineering or Technical Field.
  • Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
  • Experience in medical devices and associated regulations/standards.
  • Experience in test method development and validation
  • Experience in preparing risk assessments, FMEA and other risk documents.
  • Advanced Degree in Engineering/Technical Field
  • Experience in active implantable medical devices.
  • Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
  • Working knowledge of statistics and its application to verification and validation"
  • Design Controls & Risk Management – Proven experience leading and supporting design control deliverables, risk assessments, and FMEAs throughout product development.
  • Verification, Validation & Test Methods – Expertise in test method development, validation, and execution of design verification and validation activities.
  • Medical Device Quality & Regulations – Strong working knowledge of FDA, EU MDR, and medical device quality system requirements, including audits and compliance activities.
  • Clear and effective communication skills are a must.
  • Bachelor’s degree in Engineering or a related technical field (required).
  • Advanced degree in Engineering or a technical field (preferred).
  • Minimum 2–5 years of experience supporting medical device product development
  • Project focus: Class II imaging device
  • This role will support new product development, with multiple imaging-related projects in progress
 
Why Should You Apply?

About the Company

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ICONMA, LLC