Applied Medical

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Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.

Position Description

Join Applied Medical and play a crucial role in revolutionizing medical devices. As a Design Control Risk Management Engineer, you will be responsible for ensuring the safety and efficacy of medical devices by integrating risk management principles into the design and development processes. You’ll be 100% onsite collaborating with cross-functional teams to identify potential hazards, assess risks, and implement effective mitigation strategies throughout the product lifecycle. It’s your chance to make an enduring impact on the future of healthcare.

Key Responsibilities:

• Risk Identification: Conduct thorough risk assessments to identify potential hazards associated with medical device designs. Analyze and evaluate the severity, probability, and detectability of risks to establish a comprehensive understanding of potential issues.
• Integration of Risk Management into Design Processes: Integrate risk management principles seamlessly into the design and development processes of medical devices. Ensure risk considerations are addressed at each stage of the product lifecycle.
• Regulatory Compliance: Stay up to date on relevant regulations and standards governing medical devices. Ensure that design control and risk management processes align with regulatory requirements, facilitating successful product registrations and compliance with quality standards.
• Collaboration Across Departments: Collaborate effectively with cross-functional teams, including design, engineering, quality assurance, and regulatory affairs. Foster open communication to share risk-related insights, address concerns, and contribute to a holistic approach to product development.
• Documentation and Reporting: Maintain comprehensive documentation of risk management activities, including risk assessments, mitigation strategies, and relevant communication.

Position Requirements

• Bachelor’s degree in an Engineering or Science, Technology, Engineering, and Mathematics (STEM) field or related education and experience.
• Effective oral and written communication skills.
• Excellent technical writing skills.
• Ability to work effectively in cross-functional teams.
• Ability to read, analyze and interpret complex documents.
• Working knowledge of Microsoft Office, including Word, Excel, and Outlook.

Preferred

• Experience in the medical device industry, such as through internships or co-operative education programs (co-ops).
• Engineering capstone projects related to medical or surgical devices.
• Experience in design control and risk management procedures.
• Experience with project management tools, including Microsoft Project.
• Training in Quality Systems, including Quality System Regulation/Good Manufacturing Practice (QSR/GMP); relevant Organization for Standardization (ISO) standards.
• Training in Quality principals.
• Understanding of manufacturing, quality, and risk management standards.

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers team members to have a substantial impact, unlike conventional roles.

Benefits

• Competitive compensation range: $70000 - $90000 / year in California.
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

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.