Sr. Manufacturing Engineer

Spacelabs Healthcare; Snoqualmie (WA); On-site; USD 125,000 - 135,000; Full time

Job summary

Spacelabs Healthcare in Snoqualmie, WA is seeking a proficient manufacturing engineer specializing in electronics and PCBA replacement. You will lead process improvements, cost reduction, and ensure manufacturability with R&D collaboration.

The role requires 8+ years in manufacturing engineering, knowledge of medical device release (IQ/OQ/PQ), and strong cross-functional communication to drive quality and regulatory compliance.

Qualifications

• Bachelor’s Degree in Electronics Engineering or Manufacturing Engineering or equivalent experience.
• 8+ years of relevant manufacturing engineering experience.
• Experience in electronics design preferred.
• Related experience in medical device field.
• Knowledge of medical product release process into manufacturing (IQ, OQ, PQ, TMV, verification and validation activities).
• Excellent problem-solving and cross-functional collaboration skills.

Responsibilities

• Develop, document, improve, and own manufacturing processes. Create process plans and equipment designs and document process validations.
• Establish, simulate, design, test, and implement improvements focused on cost and quality.
• Act as SME on BOMs, drawings, specs, labels, licenses, and changes.
• Perform root cause and failure analysis for field problems related to design or manufacturing.
• Lead cross-functional initiatives impacting quality, manufacturability, cost, and supply continuity.
• Coordinate with R&D to influence product design and manufacturing strategy.
• Review and disposition nonconformities with QA & supply chain for corrective actions.
• Maintain manufacturing engineering standards and validation methodologies.
• Ensure regulatory compliance (FDA, MDD, UL, CSA etc.) and manage obsolescence issues.
• Mentor and guide Manufacturing Engineers and Technicians.

Skills

Root Cause Analysis

Cross-functional Collaboration

Problem Solving

Independent Work

Manufacturing Engineering

Electronics Design

Education

Bachelors in Electronics/Manufacturing Engineering

Tools

IQ/OQ/PQ

Verification & Validation

Job description

Overview

At Spacelabs Healthcare, you make a difference. Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

Because while we may not be at a patient's bedside, their health is still in our hands.

Spacelabs Healthcare is looking for a proficient manufacturing engineer with experience in electronics and PCBA component replacement. Responsibilities include process and design improvements, quality improvements, cost reduction, alternative component selection, qualification, and approval, as well as collaboration with R&D to ensure new products are manufacturable, testable, serviceable, and reliable. This position is part of a multi-disciplinary team; a high level of collaboration with other members is essential to the overall success of the team.

• This position is located in Snoqualmie, WA and requires 100% on-site collaboration.

Responsibilities

• Develop, document, improve, and own manufacturing processes. Create process plans and equipment designs and document process validations. Perform product and process verifications and validations.
• Establish, simulate, design, test, and implement improvements to our existing products with a focus on cost and quality.
• Act as a subject matter expert on bills of materials, drawings, specifications, labels, licenses, and associated changes.
• Complete root cause and failure analysis for field failure problems related to design or manufacturing of the product.
• Leads cross-functional initiatives that impact product quality, manufacturability, cost, and supply continuity.
• Influences product design decisions and manufacturing strategy through early engagement with R&D.
• Review, disposition, and investigate nonconformity (NMRs) and work with QA & supply chain to determine how to address it including potential rework instructions to bring to conformity.
• Establishes and maintains manufacturing engineering standards, best practices, and validation methodologies.
• Maintain the integrity and quality of our products, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA, etc.
• Resolve obsolescence and supply chain shortages through component selection or design change.
• Provides mentoring and technical guidance to Manufacturing Engineers and Technicians
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business

Qualifications

• Bachelor’s Degree in Electronics Engineering or Manufacturing Engineering or equivalent experience.
• 8+ years of relevant manufacturing engineering experience.
• Experience in electronics design preferred.
• Related experience in medical device field.
• Knowledge of medical product release process into manufacturing required (IQ, OQ, PQ, TMV, verification and validation activities is desired).
• Exhibits ability to independently analyze and solve complex issues, utilizing root cause analysis tools and implementing effective solutions.
• Exhibits ability to proactively collaborate and communicate effectively with cross-functional partners to solve problems and drive positive change for the organization.
• Experience working positively and productively in a team environment; highly collaborative. Ability to manage multiple, complex priorities within demanding timeframes.
• Problem-solving skills and organized work methods with attention to detail.
• Ability to work independently and proactively with minimal supervision.

Life at OSI

Pay may range between $125,000 -$135,000 annually.

The pay range above represents annual base salary only. Final compensation will be determined based on factors such as your job level, geographic location, date of hire, experience, job-related knowledge and skills, and education in conjunction with market and business considerations.

Base salary is one component of your total rewards package. You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP). OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits. In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty. Full-Time salaried employees are entitled to flexible time-off.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Poster Link

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.