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$79k–$100k/yr
Full-time
bachelor degree
Posted 15d ago
~40 hrs/week
Responsibilities
Develops and improves manufacturing lines, equipment, and processes to ensure high-quality medical device production. Partners with cross-functional teams to optimize efficiency and support new product introductions.
Requirements
Requires a bachelor's degree in engineering and typically over two years of experience in a regulated manufacturing environment. Must have knowledge of Lean Manufacturing, NPI processes, and medical device regulations.
Full job description
The Manufacturing Engineer develops, maintains, and continuously improves the manufacturing lines, equipment, processes, and training used on the production floor. As a hands-on owner of how manufacturing at Cadwell is done, this role ensures that production can reliably meet Cadwell’s business demands while manufacturing high quality products. The Manufacturing Engineer oversees and maintains process and equipment improvements, supports new product introductions, and partners with cross-functional teams to optimize production efficiency, quality, and consistency.
Job Duties and Responsibilities:
Creates, maintains, and continuously improves the manufacturing systems (processes, equipment, training, etc.) used to manufacture Cadwell’s medical devices, for both existing and new designs
Specifies, develops, and maintains production line test methods, processes, and fixtures; ensures test approaches are repeatable, scalable, and support Cadwell’s business needs
Troubleshoots production line issues to eliminate equipment and material as a source, and implements corrective and preventive actions on the production floor; escalates issues to engineering teams as necessary to
Identifies, scopes, and justifies capital equipment needs for manufacturing investments
Stays current with manufacturing industry practices and technologies to help keep Cadwell’s production environment robust, efficient, and scalable
Ensures processes and systems align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, 2017/745/EU Medical Device Regulation); supports internal and external audits from FDA and Notified Bodies
Supports the development and continuous improvement of Cadwell’s equipment calibration program, executing in-house and outsourced calibration activities to ensure compliance and efficiency
Partners with other departments such as R&D, Supplier Quality, IT, Production, Regulatory Affairs, and Quality Assurance to ensure smooth design transfers and efficient day-to-day operation of the production environment
Supports the Manufacturing Engineering team through the NPI and design transfer processes; helps ensure that designs and their manufacturing processes are robust and repeatable
Perform other duties as assigned
Qualifications:
Knowledge, Skills, and Abilities:
Working knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput and yield
Working knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges
Knowledge of and experience with change control processes and activities
Knowledge of design-for-manufacture concepts and their practical application during the engineering development process
Knowledge of the Manufacturing Engineering discipline as it applies to NPI, including production line setup, test procedure development, and measurement of manufacturing system performance against defined acceptance criteria
Familiarity with New Product Introduction (NPI) and the design lifecycle, with hands-on experience supporting programs from engineering development through manufacturing validation, production release, and ongoing manufacturing support of active designs
Working knowledge of Continuous Improvement processes (i.e. Lean Manufacturing - Six Sigma, Kaizen, 5S, etc.)
Familiarity with Automation and Technology Integration; exposure to practical applications of technologies and smart manufacturing integration to increase quality and reduce rework
Ability to analyze data and situations, exercise sound judgment, plan and organize work, and communicate effectively across teams
Ability to identify and communicate risk with appropriate urgency, helping keep manufacturing programs on schedule with consistent follow-through on execution
Education / Experience:
Bachelor’s degree in engineering or equivalent experience
Typically has greater than two (2) years of relevant professional or technical engineering experience
Typically has experience manufacturing regulated equipment. Ideally this experience is in a medical or similar safety-conscious, highly regulated industry
Physical Requirements and Working Conditions:
Positions working with Cadwell equipment generally may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting and carrying up to 50 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision, and 2-way written/verbal communication. More specific details may be provided as needed or requested
Extensive use of a computer will be required
Travel may be required; must be able to obtain necessary travel documents
Work hours outside normal business hours may be required at times to meet business needs
Cadwell Industries, Inc. is an Equal Opportunity Employer, and as such affirms the right of every person to participate in all aspects of employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at [email protected]
Salary Range
$79,000—$100,000 USD
Related keywords
FDA 21 CFR Part 820ISO 13485EU Medical Device RegulationNPIDesign TransferLean ManufacturingSix SigmaKaizen5SProcess EngineeringMedical DevicesCapital EquipmentCalibrationQuality AssuranceRegulatory AffairsAutomation
Since 1979, Cadwell has been true to its mission: Helping you help others.
We continually listen to our customers and improve upon our core competencies: EMG, IONM, EEG, Sleep, Consumables, and CadLink Information Management.
We are innovating, expanding and growing. Visit www.cadwell.com to learn more about our quality products, outstanding service, and exciting career opportunities.
Offices: 909 N. Kellogg St., Kennewick, WA 99336, US
Based on 2081 listings with disclosed salaries, most healthcare jobs in Washington pay between $80k–$188k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in Washington right now?
There are currently 11,371 open healthcare positions in Washington listed on Clera. New openings are added daily as companies post roles.
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Are there remote or hybrid Healthcare jobs in Washington?
Yes — 953 of the 11371 open healthcare positions offer remote or hybrid work (300 remote, 653 hybrid).
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