LC/MS Systems Manager, Clinical Diagnostics
PerkinElmer is seeking an experienced LC/MS scientist or engineer for the role of LC/MS Systems Manager, Clinical Diagnostics to support existing and new clinical diagnostic LC/MS triple quadrupole products for all phases of the product life cycle, under ISO 13485 and FDA 21 QSR 820 design control processes.
The successful candidate has experience in LC/MS triple quadrupole product development. Leading and working with cross-functional teams, he/she will lead or participate with cross functional groups to implement vetted and validated technical solutions into existing or new products, from concept through to customer support, according to design control regulations.
Under ISO 13485 and FDA design control, the LC/MS Systems Manager:
- Leads system definition, integration and verification of LC/MS designs and technologies, working with cross-functional teams in R&D, operations, marketing and quality
- Collaborates on system related activities across globally located sites
- Is responsible, alongside Quality, for the accuracy and completeness of system and hardware DHF (design history file) across the product life cycle, including Risk management processes
- Leads a team developing & executing design verification & validation protocols for new or modified products
- Works with product managers and cross-functional teams to maintain and update system requirements and risk control records
- Provides input to cross functional teams for change control and risk management
- Authorizes design changes of required design output through the company's documentation control system
- Provides technical support as needed for Design transfer and implementing the Device Master Record (DMR)
- Works with cross-functional teams to review and investigate root cause of high priority problem issues raised through customer complaint process or via manufacturing escalations.
- Determines resourcing needs to carry out new projects
Job Requirements :
EDUCATION/CERTIFICATION: BSc in a scientific discipline required; PhD preferred.
REQUIRED KNOWLEDGE: Strong, hands-on background in LC/MS triple quadrupole development; sufficient familiarity with LC/MS data acquisition and quantitation software to support software-oriented user needs and system requirements. Proficiency in MS Suite including Project, PowerPoint and Excel
EXPERIENCE REQUIRED: Minimum of 5 years of experience in LC/MS product design/development of triple quadruple mass spectrometers. Experience and knowledge of developing medical device products within ISO 13485 and/or 21 CFR 820 regulated environments is highly preferred. Experience building appropriate supporting documentation for 510k submissions is preferred.
SKILLS/ABILITIES: Leading/Working in cross-functional team, adhere to a Design / Change Control System, create and maintain Design History Files, develop & execute design verification and validation protocols/testing, technical report writing; work with risk management tools such as FMEAs, understand requirements for process validation. Provide technical / engineering expertise to assigned teams and other programs as required. Ability to clearly and effectively communicate (verbal & written) concepts, ideas, data, knowledge, etc., to individuals and teams. Execute project technical work product and deliverables as required.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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