Component Engineer

About Applied Medical

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 Component Engineer, your primary responsibility includes component management and database maintenance, design controls and verification, and risk management verification.

Component Management & Database Maintenance

You will create schematic and Printed Circuit Board (PCB) footprint symbols, ensure components meet technical specifications and material restrictions, such as Restriction of Hazardous Substances (RoHS) and Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), research component availability throughout medical device lifecycle, manage and update the component database.

Design Controls & Verification

You will document medical device compliance 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 external regulatory requirements. You will review the standards listed in the design history file of the device and document any changes between past and current revisions.

Risk Management Verification

You will prepare crucial risk management documents such as failure modes and effects analysis (FMEA) and hazard analysis. You will also document compliance gaps, and any other relevant information necessary for ensuring adherence to applicable regulations and industry standards.

Performance Objectives

Within your first six 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 Medical Learning foundational courses.

• Discuss your goals and expectations with your team leaders, 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 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

• More than two years of applicable experience

• Experience creating PCB schematic and layout symbols using Altium or other Computer-Aided Design (CAD) software

• Experience using SiliconExpert or other Bill of Materials (BOM) management software

• Experience writing and performing design verification and validation protocols

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

• Experience with hardware and software testing for medical electrical devices

• Experience with Class IIb medical device design and manufacturing processes

• Experience working with requirement management tools such as Parametric Technology Corporation (PTC) or Jama

• Experience with medical electrical device industry standards, including International Electrotechnical Commission (IEC) 60601 and International Organization for Standardization (ISO) 13485

Preferred

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 wages or compensation once 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.