Medical Device Validation/Quality Engineer (ONSITE- No H1B/C2C)

Please submit your resume only if you have a Bachelor Degree in Medical Device.

The client may consider a degree in biology, chemistry, or a clinical field.

Please don't send technical resumes; this is not a technical role.

Technical resumes will be rejected.

No H1B/C2C

Please note that this is a 1-year position.

• Prefer candidates with a BS in Medical Technology.

• Candidates with this background are better suited for the senior-level position.

• Strong understanding of the lab environment and day-to-day customer operations.

The job is 100% onsite at 100 Indigo Creek Drive (CNP location). Occasional travel is required, Client will reimburse, with 20% travel including airplane, automobile travel, and overnight hotel stays.

However, the team is open to conducting virtual interviews for candidates who are not local, with the understanding that if selected, the candidate will be responsible for their own relocation expenses.

Overtime is expected. Early or late meetings with China partners.

Qualifications:

• Experience: Candidates should have a minimum of 7-8 years of relevant experience in the V&V field. Although the position typically requires over 10 years of experience, strong candidates with slightly fewer years but a high degree of relevant expertise will be considered.

• Industry Background: A background in medical devices is ideal. However, the team will also consider candidates from pharmaceutical, biotech, or other life sciences industries where knowledge of FDA regulations and documentation practices is crucial.

• Skills:

• Senior-level experience in designing and executing test cases.

• Understanding of FDA regulations and the necessary documentation.

• Ability to review executed protocols and provide effective feedback.

• Experience with large instrument systems is preferred.

Required Skills:

• Education: B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
• Experience: 10 years, preferably in a medical device environment.
• Familiarity with software configuration management tools, defect tracking tools, and peer review.
• Instrument V&V Theory & Application.
• An understanding of IEC 62304 (Medical Device Software Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements.
• Good analytical and problem-solving skills.
• Strong organizational skills and the ability to manage multiple tasks.
• Experience in product development and experimental design.
• Ability to work within cross-functional teams.
• Strong communication skills, both written and verbal.
• Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
• Ability to participate in planning and managing projects.
• Working knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification and Validation, Product Risk Management).
• Knowledge of related quality systems regulations and processes.
• Proficiency in computer skills (e.g., email, word processing, statistical analysis, spreadsheets, and graphing software).
• Knowledge of Application Lifecycle Management (Agile method preferred).
• Understanding of the software test cycle.
• Ability to write test plans, test cases, and test reports.

Position Overview: This position is for a Senior V&V (Verification and Validation) professional, required to support a collaboration with an external vendor in China. The primary responsibilities involve designing test cases, reviewing requirements, and assisting with the execution and feedback of the verification process. The role is essential for ensuring compliance with FDA regulations and maintaining a rigorous validation process.

Project Context: The position is part of an aggressive project timeline that aims to complete the verification process by the end of the year. Once verification is complete, the team will handle the validation process in-house at Marquette QO. The project timeline is strict, requiring a senior-level individual capable of managing complex tasks and meeting deadlines without the need for extensive training.

Responsibilities:

• Test Case Design & Execution: The individual will be responsible for designing and reviewing test cases, ensuring they align with FDA regulations. This includes understanding system specifications and creating test cases that meet required standards.

• Verification Oversight: The team in China will handle the actual verification, but the individual will be integral in reviewing the execution of these tests and providing feedback.

• Documentation Review: The position will require reviewing a significant amount of incoming documentation from the external vendor, ensuring it aligns with industry standards, FDA rules, and regulations.

• FDA Regulatory Compliance: Candidates must be familiar with FDA rules and regulations, particularly regarding the design, execution, and documentation of test cases. The role requires a deep understanding of how to operate within these constraints to ensure compliance.

• Designing and implementing software for embedded devices and systems.

• Designing, developing, coding, testing, and debugging system software.

• Developing requirements-based manual test procedures.

• Assessing requirements for testability and determining the best test approach.

• Compiling and analyzing test results.

• Documenting and managing system software defects.

• Participating in regular scheduling and team meetings.

• Attending regular off-hour meetings with partners in China.

• Understanding project goals and timelines, and providing support to ensure product launch success.

• Performing other work-related duties as assigned.

Additional Considerations:

• Vendor Interaction: The individual will need to communicate effectively with the external vendor in China, providing clear feedback and guidance on the executed protocols.

• Fast-Paced Environment: The role requires someone capable of working under tight deadlines and handling a high volume of work without delays.

• Training: While training on specific instruments may be provided, the candidate must already possess the requisite knowledge of FDA rules and regulations. Training will not be provided for these foundational elements.

• Software Configuration Management Tools: No software development is involved in this role. The candidate will not need experience with software configuration management tools like SVN or GitHub. Test designs are currently being done in Microsoft Word and will eventually transition to a tool called Quality Center. However, the role does not require any direct involvement with software development or configuration management tools.

Exclusion Criteria:

• Computer Systems Validation Experience: While candidates with computer systems validation experience may have relevant skills, this role focuses on large instrument systems. Therefore, candidates with primarily computer systems validation backgrounds are unlikely to meet the qualifications for this specific role.

Education Requirements:

• The team is open to candidates with a variety of educational backgrounds. While there is no strict requirement for a specific degree, a background in bio, medical technology, computer science, or related fields is preferred. The focus is more on practical experience and critical thinking skills rather than formal education. Candidates should have the ability to think critically and apply their knowledge to complex test case designs and validation tasks.

Applicants must provide their phone number. Reference job number A4688.