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60601 Jobs in Renton, WA (NOW HIRING)

Senior Principal Engineer

Bothell, WA · On-site

$140K - $193K/yr

... 60601-1, 60601-1-2, etc.), • Mentor junior engineers in best practices in design, debugging, and documentation. • Learn and support legacy products while developing new ones. • Improve the ...

Experience with IEC 60601 or similar regulatory standards or design in a regulated environment (SEMI, MIL-STD, FAA) which requires fulfilling quality systems regulations in the design and development ...

Familiarity with AAMI ST91 and IEC 60601-2-18 standards. * Prior experience in an ISO 13485 or FDA 21 CFR Part 820 environment. Benefits * BPI Medical offers a comprehensive benefits package to ...

60601 information

What are the key skills and qualifications needed to thrive as a Medical Device Quality Engineer (IEC 60601 compliance), and why are they important?

To thrive as a Medical Device Quality Engineer specializing in IEC 60601 compliance, you need a solid background in biomedical engineering or a related field, along with knowledge of regulatory standards for medical electrical equipment. Familiarity with compliance testing tools, risk management software, and quality systems such as ISO 13485 is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for ensuring product safety and collaborating across teams. These abilities are crucial for maintaining regulatory compliance and ensuring the safety and effectiveness of medical devices in the healthcare industry.

What are 60601 standards?

The 60601 standards refer to the IEC 60601 series, which are international standards for the safety and performance of medical electrical equipment. These standards ensure that medical devices meet essential requirements for safety, reliability, and electromagnetic compatibility. Compliance with IEC 60601 is often required for medical devices to be marketed and used in hospitals and healthcare settings. The standards cover various aspects, including basic safety, essential performance, and specific requirements for different types of medical equipment.

What are common challenges faced by professionals working with IEC 60601 compliance, and how can they be addressed?

Professionals involved in IEC 60601 compliance often face challenges such as staying up-to-date with evolving standards, ensuring thorough documentation, and coordinating across departments like engineering and regulatory affairs. Addressing these challenges typically involves ongoing training, implementing robust project management tools, and fostering open communication among cross-functional teams. Regular internal audits and collaboration with external testing labs can also help ensure compliance and reduce the risk of costly redesigns or certification delays.

What is the difference between 60601 vs Medical Equipment Technician?

Aspect60601Medical Equipment Technician
CertificationsOften requires compliance with IEC 60601 standards, but not a specific certificationTypically requires certification in medical equipment repair or biomedical technology
Work EnvironmentHospitals, clinics, medical device manufacturingMedical facilities, repair shops, biomedical departments
Industry UsageStandards for medical electrical equipment safetyMaintains and repairs medical devices

While 60601 refers to safety standards for medical electrical equipment, Medical Equipment Technicians focus on repairing and maintaining such devices. Understanding 60601 is essential for technicians to ensure compliance and safety in their work.

What are popular job titles related to 60601 jobs in Renton, WA? For 60601 jobs in Renton, WA, the most frequently searched job titles are:
What job categories do people searching 60601 jobs in Renton, WA look for? The top searched job categories for 60601 jobs in Renton, WA are:
What cities near Renton, WA are hiring for 60601 jobs? Cities near Renton, WA with the most 60601 job openings:
Senior Principal Engineer

Senior Principal Engineer

Bausch Health

Bothell, WA • On-site

$140K - $193K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 6 hours ago


Job description

Senior Principal Engineer
Job Location: Bothell, Washington, USA
Job Requisition ID: 15294
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact.
Position Title: Sr. Principal FPGA Electrical Engineer
Description: This individual is responsible for the creating innovative FPGA embedded solutions for Solta's new products and processes.
FLSA Status: Exempt
Reports to: Electrical Engineering Manager
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
• Responsible for technical leadership of FPGA architecture and design in Solta embedded products,
• Define and document FPGA functional requirements,
• Hold and participate in technical design reviews,
• Design and implement FPGA solutions such as system communication, control algorithms, data movement and processing,
• Conduct laboratory test, debug, and integration activities,
• Perform and document requirement verification,
• Participate in failure mode, safety, and hazard analysis of new and legacy device designs,
• Familiarity with energy delivery modalities include ultrasound, LASER, and/or RF energy,
• Assure compliance of equipment to IEC medical device standards (60601-1, 60601-1-2, etc.),
• Mentor junior engineers in best practices in design, debugging, and documentation.
• Learn and support legacy products while developing new ones.
• Improve the tools and methods for FPGA development.
Experience, Education, Training, Skills, Traits:
• BS (MS preferred) in Electrical Engineering or equivalent experience,
• An expert level working knowledge of electrical engineering concepts/principals as they relate to digital hardware development and product development
• Minimum ten years in FPGA design and development,
• Hands-on experience with typical electronics laboratory test equipment,
• A solid working knowledge of analog/digital circuitry, EDA software (Altium), and design for manufacturability.
• Outstanding requirements and specification writing skills for regulated products/applications, including design traceability and verification and validation plans.
• Experience with IEC 60601 or similar regulatory standards or design in a regulated environment (SEMI, MIL-STD, FAA) which requires fulfilling quality systems regulations in the design and development lifecycle.
• Ability to work in a fast-paced multidisciplinary environment including software, optical, RF, and mechanical engineers and project managers.
• Skilled in problem definition, data collection and analysis, generating solid conclusions and recommendations.
• Technically creative and motivated to explore design trade-offs in the development of complex electrical and electro-mechanical systems designs.
• Ability to multi-task, and capable of executing multiple assignments on time.
• Provide direction and leadership within group
Desired technical skills:
• Solid understanding of FPGA architectures, their hardware/software interfaces, and memory interfaces (DDR, SRAM, Flash),
• Proficiency with VHDL (some Verilog),
• Proficiency with Xilinx and Altera FPGA tool flow (ISE, Vivado, Quartus),
• Proficiency with HDL simulation tools (Questa),
• Proficiency with FPGA timing closure techniques,
• Proficiency with reading electrical schematics.
• Experience with source control tools (Perforce)
• Experience with MatLab or equivalent modelling language programming
• Background in diagnostic or therapeutic ultrasound, RF, sensors is a plus
• Control system design and implementation or similar signal processing.
• Ability to work with mathematical concepts such as probability and statistical inference
• Ability to use MS Excel or equivalent to perform data analysis
The range of starting base pay for this role is 156K-215K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

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About Bausch Health

Sourced by ZipRecruiter

Bausch Health Companies Inc. is a global, diversified pharmaceutical company whose mission is to improve people’s lives with our pharmaceutical products. We develop, manufacture and market a range of products primarily in gastroenterology, neurology, dermatology and international pharmaceuticals. With our leading durable brands, we are delivering on our commitments to patients, health care providers, other stakeholders and society as we build an innovative company dedicated to advancing global health.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Laval, QC, CA

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