Compliance Engineer

As a new generation medical device company, Applied Medical is equally committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth.

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

Position Description

Areas Of Responsibility

As a Compliance Engineer, your primary areas of responsibility revolve around ensuring compliance with internal and external requirements for medical devices. This includes meticulously documenting compliance-related information and continuously improving technical documents like engineering test protocols, reports, manufacturing instructions, and manufacturing test methods. Additionally, you will actively contribute to the design control process by collaborating with cross-functional teams to establish effective controls, conducting device verification and validation testing, and preparing crucial risk management documents such as failure modes and effects analysis (FMEA) and hazard analysis. You will review the design to ensure all components and sub-assemblies meet the requirements for hazardous substances set forth by the European Union (EU), such as Restriction of Hazardous Substances (RoHS) and Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and other markets. You will review the standards listed in the design history file of the device and document any changes between past and current revisions. Moreover, you will be involved in certification testing for review by certifying bodies like Underwriters' Laboratories (UL), ensuring that the medical devices meet the necessary regulatory standards, and staying updated with changes between revisions to maintain compliance with the evolving industry standards.

Design Controls And Verification

Utilize and develop skills to document medical device compliance internally, ensuring adherence to applicable internal procedures and standards. Collaborate with cross-functional teams to verify design controls, perform device verification and validation activities, and ensure compliance with regulatory requirements and industry best practices. You will also participate in and oversee UL testing to ensure the device meets the tests per International Electrotechnical Commission (IEC) 60601-1.

Risk Management Verification

You will document various aspects related to regulatory compliance, including procedures, processes, and quality management systems. You will also document compliance gaps, and any other relevant information necessary for ensuring adherence to applicable regulations and industry standards.

Process Improvement And Collaboration

As a compliance engineer you will identify areas of improvement, analyze problems, and initiate necessary changes to enhance compliance procedures and practices within the organization. You will also collaborate with various teams, stakeholders, and departments to ensure effective communication, coordination, and alignment in implementing compliance initiatives and meeting project deadlines.

Performance Objectives

Within your first 6 months, you will be responsible for learning about our company, contributing to various projects and leading project management initiatives.

During your first 30 days, you will:

• Learn about Applied Medical's mission and vision and take part in a variety of Applied Learning foundational courses

• Discuss your goals and expectations with your team leaders and read and review all relevant team resources and materials

• Immerse yourself in team meetings and discussions

Within 60 days, you will:

• Exhibit a strong technical understanding of the product lines and projects

• Support team meetings and agendas

• Take on one or more projects that require low to moderate guidance

Within 90 days to 1 year, you will:

• Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables

• Lead moderate to complex projects with minimal guidance or direction

• Demonstrate a strong understanding of Applied Medical's Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelines

• Handle a variety of projects on your own

Position Requirements

This position requires the following skills and attributes:

• Bachelor's degree in a relevant discipline

• At least one year of applicable work experience

• Understand, analyze, and troubleshoot complex systems

• Comprehend technical documents, including standards, regulations, engineering protocols, schematics, drawings, and controlled procedures

• Team player who works well with others and succeeds in a highly collaborative environment

• Work effectively in an independent setting to resolve issues and manage multiple tasks

• Experience utilizing standard electrical tools and test equipment such as oscilloscopes, digital multimeters, and power supplies

• Effective oral and written communication skills

• Possess outstanding organizational skills, attention to detail, and project management skills

• Maintain a cooperative attitude and show initiative to assist the team

• Ability to develop a working knowledge of regulatory, manufacturing, and quality standards

Preferred

This position prefers the following skills and attributes:

• More than two years of applicable work experience

• Possess expertise in executing design verification and validation protocols

• Have a proven ability to collaborate with diverse functional groups to identify failures and hazards in alignment with design requirements

• Demonstrate proficiency in conducting thorough electrical and software testing, with a meticulous approach to documenting comprehensive outcomes

• Be capable of performing comprehensive testing for medical electrical devices

• Exhibit proficient oversight of Class IIb medical device design and manufacturing processes

• Demonstrate effective issue analysis and resolution skills within complex systems

• Be experienced in utilizing requirement management tools like Parametric Technology Corporation (PTC) or Jama to manage tasks efficiently

• Showcase an in-depth understanding of medical electrical device industry standards, including IEC 60601 and International Organization for Standardization (ISO) 13495

• Be proactive in taking initiative as a self-starter, demonstrating the ability to manage multiple projects autonomously

• Possess remarkable technical writing skills

• Display excellence in both verbal and written communication

• Have a track record of exceptional organizational and project management capabilities

• Foster cooperation and contribute proactively within a team-oriented environment

Inside This Business Group

The Technology and Development Electrical (TDE) team oversees the product development of the Advanced Surgical Device systems, exemplified through the Voyant Intelligent Energy System.  The TDE team participates in various aspects of the product lifecycle. Specifically, from ideation, development, and production. The Systems Team is a group within TDE that assists with new product development and sustaining product projects. The Systems Team ensures that risk management and design controls documentation are synchronized. The Systems Team coordinates with various departments throughout the company to ensure products meet internal and external standards, regulations, and industry best practices.

Benefits

The base compensation range for this role is $75000 - $95000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process.

Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit or any other form of compensation may be modified at the Company's sole discretion, consistent with the law.

The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans].

Our total reward package also includes the following:

• Training and mentorship with ongoing learning and development courses

• On-campus wellness activities

• Comprehensive medical and dental and vision coverage

• Education reimbursement program

• 401(k) program with discretionary employer match

• Generous vacation accrual and paid holiday schedule

All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.