Compliance Engineer II - Santa Barbara, United States - Inogen

Description

Job Summary:

The Compliance Engineer is responsible for ensuring that Inogens medical devices are designed and tested to all applicable domestic and international regulations and standards, and for ensuring appropriate documentation in the Design History File. It is necessary for the Compliance Engineer to stay up to date on changes made between revisions of standards and regulations to maintain compliance with evolving industry standards. In addition, the Compliance Engineer will be the technical point of contact that coordinates and oversees external agency testing. Cross-functional collaboration as part of project teams will be required to drive product compliance throughout the product life cycle. Meticulous attention to detail is required for documenting compliance-related information, including test protocols and reports.

Responsibilities (Specific tasks, duties, essential functions of the job)

Compliance Engineer I

• Ability to create design control documentation and execute activities in accordance with Inogen procedures, FDA guidance, and ISO 13485 requirements.
• Stay up to date on current standards and document changes between past and current revisions.
• Verify standards compliance, alignment, and traceability linkages through product design history files.
• Facilitate, support and /or execute verification and validation(V&V) testing of device components and systems both internally and with external agencies.
• Develop a strong technical understanding of product lines.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.

Compliance Engineer II

In addition to items listed for the Compliance Engineer I, the Compliance Engineer II may also be responsible for the following.

• Coordinate the planning and completion of design validation and verification activities for new products and product changes including engineering V&V activities as well as communicating changes in specifications or documentation to appropriate departments.
• Coordinate and oversee applicable compliance testing with external labs for product release and product changes as required.
• Act as the technical resource for product documentation, including technical and user manuals in compliance with applicable standards and guidance documents.

Compliance Engineer III

In addition to items listed for the Compliance Engineer II, a Compliance Engineer III may also be responsible for the following.

• Establish and execute assigned design control activities for development projects in conjunction with operations, project management, regulatory, and engineering collaboration.
• Ensure product design requirements and verification outputs are aligned with current applicable domestic and appropriate international standards and traceable through the appropriate design control documentation.
• Works cross-functionally to drive projects to completion, including compliance testing and regulatory activities.
• Independently plans, executes, and documents system level testing to applicable domestic and international standards and agency requirements.
• Supports internal and external audit activities, demonstrating compliance verification as applicable.
• Prepare crucial risk management documents such as failure modes and effects analysis (FMEA) and hazard analysis.

Compliance Engineer IV

In addition to items listed for the Compliance Engineer III, a Compliance Engineer IV may also be responsible for the following.

• Works with Design Quality Engineering to manage and implement changes to the design control process at a systemic level to increase efficiency and ease of compliance verification.
• Responsible for coaching and mentoring other Compliance Engineers
• Maintains understanding of current and upcoming procedures, regulatory, and guidance documents, performs assessments for impact against Inogens product portfolio, and implements changes in collaboration with the cross-functional team.

Knowledge, Skills, and Abilities

• Must have a strong work ethic.
• Ability to comprehend technical documents, including standards, regulations, engineering protocols, schematics, and engineering drawings.
• Excellent oral and written communication skills required.
• Ability to effectively collaborate with different departments within the company.
• Ability to resolve conflicts within the cross-functional team.
• Utilize analytical & problem-solving skills to manage complex project deliverables.
• Solutions-oriented problem solver.
• Attention to detail with accurate and complete documentation.
• Excellent planning, communication, and organizational skills.
• Must be able to plan, prepare, and hold design reviews for projects.
• Must be able to support internal and external audit activities.
• Required knowledge of good documentation practice and laboratory procedures.
• Required experience supporting international product registrations and in-country testing requirements.

Qualifications (Experience and Education)

Level I

Compliance Engineer I

• Bachelors in Engineering or related Scientific field of study, required.
• 1-3 year of research laboratory environment experience, required.
• Medical manufacturing experience, preferred.
• Basic knowledge and experience with ISO 13485, required.
• Basic knowledge in FDA, GMP, and quality systems, required.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level II

Compliance Engineer II

• Bachelors in Engineering or related Scientific field of study, required.
• 3+ years experience in medical device design control compliance testing, required.
• 2+ years of medical device design experience, preferred.
• Intermediate knowledge/and experience with ISO 13485, required.
• Intermediate knowledge in FDA, GMP, and quality systems, required.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level III

Compliance Engineer III

• Bachelors in Engineering or related Scientific field of study, required.
• Masters in Engineering or related Scientific field of study, preferred.
• 5-7 years experience in medical device industry, required.
• 3+ years experience in medical device design control compliance testing, required.
• Advanced knowledge and experience with ISO 13485, required.
• Advanced knowledge in FDA, GMP, and ISO regulated quality systems, required.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level IV

Compliance Engineer IV

• Bachelors in Engineering or related Scientific field of study, required.
• Masters or Doctorate in Engineering or related Scientific field of study, preferred.
• 7+ years of experience in medical device industry, required.
• 3+ years experience in design control systems and requirements, UL and/or CSA compliance testing, required.
• Expert knowledge and experience with ISO 13485, required.
• Expert knowledge in FDA, GMP, and ISO regulated quality systems, required.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.