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.
- 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