Senior Research Scientist

Siemens Healthineers AG; Ottawa; On-site; CAD 110,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Pension plan

Paid time off

Job summary

Siemens Healthineers AG seeks a Senior Research Scientist to oversee verification and validation for handheld devices, supporting regulatory submissions and post‑market documentation. The role demands independence, technical depth, and collaboration with Regulatory, Clinical Affairs, Marketing, and R&D teams.

Responsibilities include study design, data interpretation, and preparing technical reports while coordinating supply logistics and contributing to customer bulletins and white papers.

Qualifications

• Master’s or PhD in a relevant technical discipline.
• Minimum 8 years of clinical research experience in medical devices, healthcare, or pharmaceuticals.
• Expertise in point‑of‑care blood gas and chemistry analysis in diagnostics or clinical labs.
• Proven ability to interface with external sites and build collaborations.
• Strong organizational and time management with attention to detail.
• Excellent written and verbal communication; able to present to stakeholders.

Responsibilities

• Plan and execute internal validation, preliminary evaluations, and post‑market studies.
• Conduct data acquisition and analysis for validation studies and create technical reports.
• Prepare regulatory summaries and support submissions (FDA, IVDR, CLIA).
• Manage investigational product logistics and collaborate with export controls, shipping, and sites.
• Develop customer-facing collateral and contribute to cross‑functional documentation.
• Mentor colleagues and drive cross‑functional teamwork across Regulatory, R&D, Quality, and Marketing.

Skills

Data analysis

Excel

JMP

Clinical research

Regulatory knowledge

Communication skills

Mentoring

Team collaboration

Project management

Travel readiness

Education

Master's or PhD in a technical discipline

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.Position OverviewUnder the supervision of the Manager, Stability, Verification and Validation (Handheld), the Research Professional oversees verification and validation activities for both new and on‑market products in support of regulatory submissions and post‑market documentation.The role operates at a scientist level and requires a high degree of independence and technical expertise. Responsibilities include technical development and experimental screening, as well as the design, execution, and interpretation of complex studies with minimal supervision. The Senior Research Scientist engages and collaborates with cross‑functional stakeholders, including Regulatory Affairs, Clinical Affairs, Marketing, Product Health, Research and Development, and Stability, Verification and Validation.ResponsibilitiesManages planning and execution activities for internal validation, preliminary evaluations, continuous improvement initiatives, product portfolio life‑cycle management, and post‑market evaluations. This includes protocol development and study design, document management.Performs data acquisition for a broad range of in‑house and field verification and validation studies, including but not limited to Alpha studies, method comparison, precision, limit of quantification, and interference testing.Compiles, analyzes, and clinically interprets study data, and prepares technical reports and support regulatory summaries.Manages investigational product supply logistics, working closely with Export Control and Customs specialists as well as Shipping and Receiving to ensure timely delivery to collaboration sites and to resolve logistical issues as needed.Contributes to the development of customer‑facing collateral, including case studies, proof points, white papers, and customer bulletins, in close collaboration with R&D, Quality, Regulatory, and Marketing.Supports preparation of regulatory submissions, including but not limited to FDA Pre‑Submissions, FDA 510(k) submissions, IVDR submissions, and CLIA Waiver applications, as required.Required Knowledge, Skills, Education, and ExperienceMaster’s or PhD's degree in a relevant technical discipline, or an equivalent combination of education and applicable technical experience.Minimum of 8 years of clinical research experience in the medical device, healthcare, or pharmaceutical industry.Demonstrated expertise in point‑of‑care blood gas and chemistry analysis within the medical diagnostics or clinical laboratory environment.Proven ability to interface professionally with external sites and to establish and maintain effective working relationships and collaboration agreements.Demonstrated success in managing complex, high‑level technical assignments with minimal oversight.Highly organized and detail‑oriented, with strong time‑management and prioritization skills.Strong ability to work collaboratively in a team environment, with a demonstrated commitment to mentoring and developing others.Proficient in the use of data collection and analysis tools, such as Excel and JMP.Willingness to proactively identify issues, raise concerns, and propose practical solutions.Excellent written and verbal communication skills.Comfortable developing and delivering presentations to internal and external stakeholders in both one‑on‑one and group settings.Preferred Knowledge, Skills, Education, and ExperienceIn‑depth understanding of the epoc blood analysis system, with the ability to apply this knowledge to troubleshoot issues related to sample preparation, testing protocols, workflows, and product performance.Experience in launching a commercial product.Ability and willingness to travel upon request (less than 25%)Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.To find out more about Siemens Healthineers' businesses, please visit our company page at Siemens Healthineers Canada.The expected compensation for this position is:Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.Siemens Healthineers offers a variety of health and wellness benefits including a flexible benefits plan, Defined Contribution Pension Plan, Registered Retirement Savings Plan matching contributions, plus a competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements).This information is provided per required laws and regulations. Applicants should apply via Siemens Healthineers external or internal careers site.Equal Employment Opportunity Statement: Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted.Accessibility: Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities. Siemens Healthineers will strive to ensure that policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005. Siemens Healthineers will continue to attempt to meet the needs of all its customers, including but not limited to persons with disabilities, in an effective and timely manner.If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.By submitting personal information to Siemens Healthineers or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Notice here.To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.