Technical Operations Specialist
About The Position
The Technical Operations Specialist will serve as the primary subject matter expert of our refurbished parts program, owning the technical process for managing these components from qualification through sustainment. You will be responsible for leading the technical qualification and ongoing sustainment of refurbished service parts, collaborating closely with R D, Quality, Operations, other internal stakeholders and our external supplier. You will manage and speak on behalf of the refurbished parts process during internal reviews, with stakeholders, and during audits. This role requires not only strong technical acumen but also strong collaboration and communication skills to partner with cross-functional teams to progress qualification projects and problem solve obstacles. Your expertise will have a direct impact on our global service efficiency and customer satisfaction. In this role, you will have the opportunity to: Lead and own the creation and execution of critical design control documentation, including Design Control Input Assessments (DCIAs), Test Item Approvals (TIAs), and elements of the Design Control Process (DCP). Lead the Design Transfer Review process to ensure smooth transition of qualified parts. Evaluate, update, and create comprehensive work instructions for refurbished part builds. Be accountable for identifying, specifying, and driving to completion required Bill of Material (BOM) updates or creation, related Engineering Change Orders (ECOs), and new part number creation. Create the Component Qualification Plan, ensuring all technical requirements are met. Develop and execute Test Equipment Installation Qualification (IQ) and Operational Qualification (OQ) protocols and reports. You will also be comfortable creating test protocols for the verification of parts. Train the external supplier on Beckman Coulter's refurbished part procedures and specifications, ensuring their processes align with our quality standards. Opportunity identification: Proactively identify opportunities to qualify additional refurbishment items. Develop and present Return on Investment (ROI) analyses for new refurbishment opportunities to guide decision-making.
Requirements
- A Bachelor's degree with 2+ years of experience in technical operations, service engineering, quality engineering, or product qualification within a regulated industry, or a Master's degree with 0-2 years of experience.
- Demonstrated experience with part qualification, validation, and sustaining activities, including experience with design control processes.
- Proficient in reading, interpreting, and creating technical documents, Bills of Materials (BOMs), and work instructions.
- Exceptional analytical and problem-solving skills, with a strong ability to perform root cause analysis, implement effective solutions, and clearly communicate related information to stakeholders.
- Ability to travel up to 10% both domestic and internationally
Nice To Haves
- Strong interpersonal skills, enabling effective collaboration with cross-functional internal teams and external partners, with the ability to drive teams to action, manage timelines, and overcome challenges by engaging appropriate subject matter experts.
- Strong understanding of the Design Controls Process (DCP) and associated documentation (DCIA, TIA) and experience with IQ/OQ protocols and reports for test equipment and part verification.
- Hands on experience with refurbished products and medical diagnostic systems.
- Experience with ERP systems (e.g., Oracle) and Quality Management Systems (QMS) software (e.g., MasterControl).
Responsibilities
- Lead and own the creation and execution of critical design control documentation, including Design Control Input Assessments (DCIAs), Test Item Approvals (TIAs), and elements of the Design Control Process (DCP).
- Lead the Design Transfer Review process to ensure smooth transition of qualified parts.
- Evaluate, update, and create comprehensive work instructions for refurbished part builds.
- Be accountable for identifying, specifying, and driving to completion required Bill of Material (BOM) updates or creation, related Engineering Change Orders (ECOs), and new part number creation.
- Create the Component Qualification Plan, ensuring all technical requirements are met.
- Develop and execute Test Equipment Installation Qualification (IQ) and Operational Qualification (OQ) protocols and reports.
- Create test protocols for the verification of parts.
- Train the external supplier on Beckman Coulter's refurbished part procedures and specifications, ensuring their processes align with our quality standards.
- Proactively identify opportunities to qualify additional refurbishment items.
- Develop and present Return on Investment (ROI) analyses for new refurbishment opportunities to guide decision-making.
Benefits
- comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
- This job is also eligible for bonus/incentive pay.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
