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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading technical investigations for MDS instrumentation complaints, managing cross-functional teams, and ensuring compliance with FDA and ISO requirements. Proficient in evaluating complex systems, conducting diagnostic testing, and improving investigation processes.
Highest-signal resume keywords
Technical Investigation LeadershipDesign Verification and ValidationCross-Functional Team ManagementLaboratory Troubleshooting and Diagnostic TestingFDA and ISO Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design VerificationDesign ValidationLaboratory TroubleshootingDiagnostic TestingTechnical Documentation ReviewRisk ManagementStatistical Data InterpretationMulticomponent Equipment SystemsSoftware EvaluationComplaint Investigation Process Improvement
Soft Skills
Team LeadershipCoaching and DevelopmentCommunicationProblem SolvingRelationship Management
Industry Keywords
MDS InstrumentationQuality AssuranceCAPAField ActionsServiceability ImprovementsOperational WorkflowsAssaysConsumablesTechnical BulletinsVerification Documents
About the role
Key responsibilities & impact- Lead the end-to-end technical investigation process for MDS instrumentation complaints
- Review and provide final technical approval of complaint investigations
- Perform and direct laboratory and instrument work to reproduce failures and conduct diagnostic testing
- Evaluate interactions among instrument hardware, software, consumables, assays, and operational workflows
- Initiate or recommend CAPA, risk-management updates, design changes, field actions, serviceability improvements, and product-improvement projects
- Serve as the technical interface with Quality Assurance for complaint handoffs, priorities, status, approvals, and conclusions
- Manage relationships with Service and Support leadership, including third-level escalations and field evidence
- Review and approve technical documentation, including investigation reports, procedures, work instructions, troubleshooting guides, diagnostic materials, service information, technical bulletins, requirements, risk-management updates, verification documents, and design-change documentation
- Improve complaint investigation processes and establish consistent investigation and documentation standards
- Represent PD&S in cross-functional governance forums and coordinate schedules and delivery commitments with project managers and product owners
- Directly manage the PD&S team, including hiring, onboarding, objective setting, performance reviews, coaching, development planning, recognition, promotion recommendations, and corrective performance management
- Resolve technical disagreements, set priorities, assign decision owners, remove roadblocks, and communicate technical findings and recommendations to leaders
Requirements
What you’ll need- Bachelor's Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc.), Life Sciences, or equivalent
- 9+ years of experience in design verification or validation, with a significant portion including software
- 4+ years of direct management experience working with cross-functional teams
- 4+ years of experience with medical equipment or other complex, multicomponent equipment systems, including lab automation
- Experience reviewing and approving requirements, investigation records, traceability information, risk-management updates, and supporting technical documentation
- Ability to interpret basic technical and statistical data used to evaluate product performance and compare test results
- Knowledge of applicable FDA and ISO requirements
- Experience with laboratory and instrument troubleshooting, diagnostic testing, system logs, service records, hardware, software, consumables, assays, and operational workflows
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(k) match
- Tuition reimbursement
- Professional growth and career progression opportunities