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60601 Jobs in Renton, WA (NOW HIRING)

Bausch & Lomb

Senior Principal Engineer (15294)

Bothell, WA · On-site

$140.30K - $193.40K/yr

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 ...

Bausch Health

Senior Principal Engineer

Bothell, WA · On-site

$140.30K - $193.40K/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 ...

BPI Medical

Instrument Repair Technician

Fife, WA

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 ...

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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 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 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 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 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:
60601 jobs near you
Senior Principal Engineer Aesthetic Medical Device (Bothell, WA)

Senior Principal Engineer Aesthetic Medical Device (Bothell, WA)

Bausch Health

Bothell, WA • On-site

$155K - $215K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 13 days ago

Job description

Senior Principal Engineer Aesthetic Medical Device (Bothell, WA)
Job Location: Bothell, Washington, USA
Job Requisition ID: 15104
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.
A strong electronic design engineer team member capable of working from requirements through system level documentation and in all facets of the electronics hardware development process with an emphasis on analog, and sensor development with analysis skills.
Responsibilities and Duties:
  • Demonstrated project and team leadership people skills
  • Mentor less experienced engineers in skills.
  • Design of circuits incorporating RF circuitry, analog controls, transducers, and sensors for an array of dermatology products utilizing RF, LASERs, and ultrasonic energy-based devices.
  • Perform electronics schematic capture and supervise CAD layout resources.
  • Develop and have constructed system and periphery electronic board prototypes.
  • Hands-on laboratory debug and integration activities to test and verify your hardware designs;
  • Hold and participate in technical design reviews;
  • Incorporate DFM and EMC principles for new and existing medical device designs.
  • Familiar with change process and configuration management tools
  • Assure equipment compliance to IEC medical device standards (60601-1, 60601-1-2, etc.).
  • Systems level failure mode, safety, and hazard analysis participation.
  • Support Manufacturing and Service departments in reliability and failure analysis investigations and solutions.
  • Learn and support legacy products while developing new ones.

Experience, Education, Training, Skills, Traits:
  • BS (advanced degree preferred) in Electrical Engineering or equivalent experience
  • Minimum 15 years in analog and digital systems design for medical devices, including experience in the development of devices for clinical application of RF energy.
  • Candidate must have substantial experience with system-level electrical design and integration, design for EMC, signal integrity, power supply systems development, and RF immunity.
  • Experience working in a multidisciplinary environment including software, optical, RF, mechanical and project management disciplines.
  • Hands-on development experience: circuit development, test and analysis for RF, laser, and ultrasound products, application of thermal heating in a therapeutic or clinical application. Understanding of standards and safety in application energy to the human body.
  • Experience with mixed signal circuit board development utilizing embedded microprocessors and FPGAs is a plus.
  • Demonstrated sound regulatory approaches to technical solutions for medical devices.
  • A solid working knowledge EDA CAD tools and design for manufacturability and test is required.
  • Skilled in problem definition, data collection, and analysis including generating supported conclusions from large data sets, and drawing conclusions that support recommendations
  • Demonstrated experience in design best practices including FDA risk management and design for EMC, safety, and manufacturability.
  • Excellent demonstrated documentation skills in regulated products/applications, including design traceability, specifications, requirements, and V&V plans.
  • Prefer experience with regulatory standards or design in a regulated environment (IEC 60601-x, ISO, MIL-STD, FAA). Foreign regulator experience is a plus.

Desired technical skills:
  • Understanding analog power output, analysis, test methodologies, transducers, and modelling are required
  • Background in clinical application of laser, RF and ultrasound energy is a plus
  • Experience designing with these components: RF amplifiers, impedance matching-networks, transformers, embedded processors, power electronics, A/Ds, DACs, op-amps, FETs, power supplies, working from prototype to full product release and applying creative test and verification methods that demonstrate requirements fulfillment (Microsoft Office, SPICE, Altium, etc.)
  • Experience with data analysis and software for data collection using Matlab, Python or another programming language is a plus

The range of starting base pay for this role is $155K-$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

Social media

Twitter

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