Manager, Product Development & Support

Grifols; San Diego (CA); Presencial; USD 145 000 - 175 000; Tempo integral

Resumo da oferta

Grifols in California is seeking a Manager, Product Development & Support to lead the PD&S engineering team on technical complaint investigations across the MDS Instrument portfolio. You will act as the primary technical interface, perform lab testing, troubleshooting, and complex investigations to support reliability and regulatory compliance.

You will review investigations, approve evidence, root-cause analysis, and recommended actions, and coordinate with QA and service leadership to drive

Qualificações

• Experience reviewing investigation records, traceability, and risk-management updates.
• Ability to interpret technical and statistical data to support conclusions.
• Sets clear priorities and removes cross-functional roadblocks.
• Translates complex findings into product impact and regulatory risk.

Responsabilidades

• Leads end-to-end technical investigations for instrumentation complaints for MDS instruments.
• Reviews and approves investigations, ensuring evidence, RCA, conclusions, and actions meet FDA/ISO requirements.
• Performs hands‑on lab work, reviews logs, runs diagnostics, and evaluates interactions of hardware, software, and workflows.
• Maintains final PD&S authority on technical conclusions and initiates CAPA and product‑improvement actions.
• Manages PD&S communications with QA and coordinates serviceability input across instruments.

Conhecimentos

Leadership

Technical leadership

Investigation

Regulatory compliance

Lab testing

Cross-functional collaboration

Data interpretation

Formação académica

Bachelor's degree

Descrição da oferta de emprego

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.

Primary Responsibilities for Role

• 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.

Additional Responsibilities

• 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.

Knowledge, Skills, and Abilities

• 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.
• 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.

Education

• Bachelors Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent.

Experience

• 9+ yrs experience testing instruments 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

The estimated pay scale for Manager, Product Development and Support role based in California, is $145,000 - $175,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. 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!

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.