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About the Role
The Manager, Product Development & Support leads the Product Development & Support (PD&S) engineering team responsible for technical complaint investigations across the MDS Instrument portfolio. This role serves as the primary technical interface across the organization while remaining actively engaged in laboratory testing, technical troubleshooting, and complex investigations. Through direct technical leadership, process improvement, documentation approval, and participation in cross-functional governance, the Manager ensures complaint findings support product reliability, regulatory compliance, and effective lifecycle management.
Responsibilities
- Leads the end-to-end technical investigation process for instrumentation complaints involving MDS instrumentation, ensuring investigations are prioritized, assigned, executed, reviewed, approved, and returned to Quality Assurance within established expectations.
- Reviews and provides final technical approval of complaint investigations prepared by the PD&S team, ensuring the investigation strategy, supporting evidence, root-cause analysis, conclusions, and recommended actions are complete, technically sound, traceable, and compliant with applicable FDA and ISO requirements.
- Performs and directs hands-on laboratory and instrument work reproducing reported failures, reviewing system logs and service records, executing diagnostic testing, and evaluating interactions among instrument hardware, software, consumables, assays, and operational workflows.
- Maintains final authority within PD&S over technical conclusions and initiates or recommends appropriate follow-up actions, including CAPA, risk-management updates, design changes, field actions, serviceability improvements, and product-improvement projects.
- Owns the technical interface with Quality Assurance for complaint handoffs, investigation priorities, status communication, technical approval expectations, supporting evidence, and resolution of technical conclusions.
- Manages the working relationship with Service and Support leadership by establishing third-level escalation expectations, resolving priority conflicts, securing required field evidence, communicating approved technical conclusions, and coordinating serviceability input across the supported instrument portfolio.
- Reviews and approves PD&S-owned technical documentation, including complaint investigation reports, investigation procedures, work instructions, troubleshooting guides, diagnostic materials, service information, technical bulletins, requirements, risk-management updates, verification documents, and design-change documentation generated by the team.
- Improves the technical complaint investigation process, establishes consistent investigation and documentation standards, represents PD&S in applicable cross-functional governance forums, and coordinates technical schedules and delivery commitments with assigned project managers and product owners.
- Directly manages PD&S team including hiring, onboarding, objective setting, performance reviews, coaching, development planning, recognition, promotion recommendations, and corrective performance management.
- Resolves disagreements by focusing on available technical evidence, product risk, applicable requirements, and the decision needed to move the investigations forward.
- Sets clear priorities, assigns decision owners, and removes technical or cross-functional roadblocks before they affect investigation quality or delivery commitments.
- Translates complex technical findings into direct explanations of product impact, regulatory risk, available options, and recommended actions so leaders can make informed decisions.
- Provides clear and timely feedback to team members, addresses performance or execution issues directly, and steps into the technical work when the team needs additional guidance or authority.
Requirements
- Experience with reviewing and approve 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, compare test results, and support technically defensible investigation conclusions.
- 9+ yrs experience in design verification or validation, with a significant portion including software
- 4+ yrs of direct management experience working with cross functional teams.
- 4+ yrs experience with medical equipment or other equipment experience involving complex, multicomponent systems, including lab automation
Skills
- Technical leadership
- Process improvement
- Documentation approval
- Cross-functional governance
- Technical troubleshooting
- Laboratory testing
- Complex investigations
- Product reliability
- Regulatory compliance
- Lifecycle management
- Quality Assurance
- Risk management
- Design changes
- Field actions
- Serviceability improvements
- Product improvement projects
- Service and Support management
- Technical documentation review
- CAPA
- FDA requirements
- ISO requirements
- Software
- Medical equipment
- Lab automation
Location
- NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
Work Type
- Full-time
Experience Level
- 9+ years in design verification or validation
- 4+ years of direct management experience
- 4+ years experience with medical equipment or other equipment experience involving complex, multicomponent systems, including lab automation
Education Level
- Bachelors Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent.
Salary/Compensations
- $145,000 - $175,000 per year
- Eligible to participate in up to 8% of the company bonus pool.
Benefits
- Medical
- Dental
- Vision
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
About the Company
- Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world.
- We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
- Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results.
- Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture.
- Our company has more than tripled over the last 10 years, and you can grow with us!
Equal Opportunity
- Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.
- We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.