Director of Assay Development and Consumables Integration - Handheld Systems

About the role

Siemens Healthineers is looking for a results-driven R&D leader to head its Assay Development and Consumables Integration team within the Handheld Systems organization. You will lead end-to-end development of assay chemistry and consumable components for point-of-care handheld blood gas instruments, as a member of the Handheld R&D leadership team reporting to the VP of R&D.

Key responsibilities

• Manage, mentor and develop a multidisciplinary team of scientists and engineers in assay chemistry and consumable development.
• Own end-to-end development of next-generation blood gas assays (test menu expansion) and consumables such as test cards and sample collection devices.
• Set product requirements and specifications using science, statistical methods and industry best practices.
• Integrate assay chemistry with consumable design and work with the SDI team on hardware-software-assay interoperability and with the lifecycle engineering team on sensor calibration and data analytics.
• Sustain on-market assays and consumables, own design changes due to obsolescence, and oversee manufacturing processes and design transfers.
• Ensure compliance with FDA QSR, ISO 13485, IVDR and ISO 14971, maintain design history files and risk management documentation, and track KPIs such as assay performance, consumable yield/cost and project milestones.

Required profile

• Bachelor's degree in Chemistry, Biochemistry, Biomedical/Chemical Engineering, Engineering or a related field; an advanced degree is strongly preferred.
• At least 12 years of progressive experience in the IVD or medical device industry.
• Demonstrated success bringing point-of-care diagnostic products to market.
• Ability to lead multidisciplinary R&D teams and communicate with senior stakeholders across R&D, Quality, Regulatory, Manufacturing, Marketing and external partners.

Required skills

• Electrochemical sensor development, reagent chemistry optimization and microfluidics.
• High-volume consumable manufacturing (e.g. injection molding, automation equipment).
• Design controls and global regulations (FDA QSR, ISO 13485, IVDR, ISO 14971).

What we offer

• Expected compensation of $110,000 - $157,000, depending on geography, skills, education and experience.
• Flexible benefits plan, defined contribution pension plan and RRSP matching.
• Paid time off including vacation, company holidays, sick leave and parental leave.