LC/MS Clinical Diagnostics Product Development Platform Manager

Organization
PerkinElmer, Inc.
Job Location
Bolton, ON
Canada
Job Description

PerkinElmer is seeking an experienced LC/MS scientist for the role of Product Development Platform Manager, LC/MS Clinical Diagnostics. The Platform Manager will support PerkinElmer product development on existing and new clinical diagnostic LC/MS triple quadrupole products for all phases of the product life cycle, from product concept through to customer support, under ISO 13485 and FDA 21 QSR 820 design control processes.

The successful candidate has experience in LC/MS triple quadrupole hardware development. Leading and working with cross-functional teams, which may include hardware and software research and development, manufacturing, service, marketing and quality, he/she will articulate and quantify customer needs and requirements, translating them into product requirements and specifications, according to design control regulations; participate with cross functional groups to implement vetted and validated technical solutions into commercially viable new products; and utilize design control, maintaining the DHF and supporting the DMR.

Responsibilities:

  • Provide leadership of the Product Development Team; determines resourcing needs to carry out development projects.
  • Work with research teams to implement new designs and technologies under ISO 13485 and FDA design control;
  • Work within the company’s design control process compliant with ISO 13485 and 21 CFR 820 requirements
  • Create and maintain design history files (DHF) for each medical device type or family.
  • Maintain and control design changes l of required design output through the company’s documentation control system; provide technical support as needed for the Device Master Record (DMR)
  • Apply risk assessment tools and methodologies, during product development to address risk management requirements
  • Work with the product development team to develop & execute design verification & validation protocols in both a hands-on and supervisory capacitySpecify critical requirements for and support process validation activities including FAI/FAT and IQ/OQ/PQ
  • Work with cross-functional teams to translate Voice of Customer (VOC) into functional requirements
  • Review and investigate root cause of high priority problem issues; implement processes to reduce the risk of similar issues in the future
  • Escalation point for production support issues; investigate, understand and assist in the resolution
  • Escalation points for product and service issues; delegate and follow through to resolution
Requirements

EDUCATION/CERTIFICATION:
BSc in a scientific discipline required; PhD preferred.

REQUIRED KNOWLEDGE:
Strong, hands-on background in LC/MS triple quadrupole hardware design and 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 and project engineering 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.

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