Director, IVD Assay & Consumables Integration

Siemens Healthineers; Ottawa; On-site; CAD 110,000 - 157,000; Full time

Benefits offered by this job

Flexible benefits plan

Defined Contribution Pension Plan

RRSP matching contributions

Paid time off program

Job summary

Siemens Healthineers Canada seeks a results-driven R&D leader to head the Assay Development & Consumables Integration team within Handheld Systems. You will drive end-to-end development of assay chemistry and consumables for point-of-care blood gas instruments, reporting to the VP of R&D.

The role requires deep IVD expertise, a track record of launching diagnostic products, and strategic acumen to align with regulatory and business goals.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biomedical/Chemical Engineering, Engineering or related field.
• 12+ years in the IVD or medical device industry.
• Experience with electrochemical sensor development, reagent chemistry, and microfluidics.
• Experience with high-volume consumable manufacturing processes.
• Strong knowledge of FDA QSR, ISO 13485, IVDR, ISO 14971 risk management.

Responsibilities

• Manage, mentor, and develop a multidisciplinary team of scientists and engineers.
• Represent the team as a core member of Handheld Systems R&D leadership to shape product strategy.
• Own end-to-end development of next-generation blood gas assays and consumables.
• Establish rigorous product requirements and specifications using sound science.
• Serve as primary integrator between assay chemistry and consumable design.
• Partner with SDI team for hardware-software-assay interoperability.
• Collaborate with Lifecycle engineering for sensor calibration and data analytics.
• Provide technical leadership for sustaining on-market assays and consumables.
• Oversee design changes due to obsolescence with risk assessment and change control.
• Oversee robust manufacturing processes and ensure quality in high-volume production.

Skills

Leadership

Strategic thinking

Communication

Problem solving

Education

Bachelor’s degree in Chemistry/ Biochemistry/ Engineering

Advanced degree preferred

Tools

Design controls

Job description

Siemens Healthineers Canada seeks a results-driven R&D leader to head the Assay Development & Consumables Integration team within Handheld Systems. You will drive end-to-end development of assay chemistry and consumables for point-of-care blood gas instruments, reporting to the VP of R&D.

The role requires deep IVD expertise, a track record of launching diagnostic products, and strategic acumen to align with regulatory and business goals.