Solution Engineer

Siemens Healthineers AG; Ottawa; Remote; CAD 72,000 - 103,000; Full time

Benefits offered by this job

Health benefits

Pension plan

RRSP matching

Paid time off

Parental leave

Job summary

Siemens Healthineers Canada is hiring a Solution Engineer to develop and execute process improvements and validation protocols for Epocal products in a CGMP/QMS environment. You will lead protocol creation, testing, and reports, partnering with engineering, operations and QA to ensure compliant, robust manufacturing processes.

Ideal candidates hold a relevant engineering degree, with 3+ years in process development/validation and familiarity with JMP or Minitab for statistical analysis.

Qualifications

• Undergraduate degree in Chemical or Mechanical Engineering required or equivalent.
• M.Sc. preferred; relevant disciplines may be considered.

Responsibilities

• Develop and execute process improvements and validation protocols.
• Draft and modify validation protocols for utilities, facilities, equipment, and processes.
• Lead execution of validation tests and drive the release of reports.
• Collaborate with engineering, operations, QA, and external contractors.
• Apply statistical methods to justify improvements and monitor process control.

Skills

Process development

Process validation

Statistical analysis

Communication

Project management

Education

Bachelor's degree in Chemical or Mechanical Engineering

M.Sc. would be an advantage

Tools

JMP

Minitab

Job description

## Solution EngineerApply: Office Based: YOW B: Full time: Posted Today: R-31835Join 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.Under the supervision of the Manager, Mechanical Process Engineering; the Solution Engineer is responsible for developing and executing process improvements and for generating and completing other technical activities and documents (e.g. Process and Equipment Validation protocols, Engineering Reports, Engineering Changes, Designed Experiments, Failure Modes and Effects Analysis, Test Method Developments) to support the efficient manufacturing of Epocal’s products in a manner consistent with CGMP and the Epocal QMS. **What will you do?*** Proactively identifies the need for process development and improvement initiatives and takes the lead on defining and implementing these initiatives. Improvements include more robust process control methodologies for existing processes. Where required, understands and uses appropriate statistical techniques to justify the efficacy and reliability of proposed improvements.* Understands the Epocal Quality Management System and be able to successfully operate within its constraints.* Establishes productive relationships with personnel from engineering, operations, quality assurance and other groups, including external contractors.* Takes the lead on drafting new utilities, facilities, equipment and/or process validation protocols or modifying existing ones according to required process or product changes. Use established relationships with other groups to gather the required information for the protocols.* Organizes and participates in required execution of validation protocols and drive the release of the corresponding report. Ensure that all groups affected by the execution are informed and are contributing appropriately.* Communicates with supervisor and others when issues are detected, and improvements required.* Participates in test method improvements, Root Cause Analysis, pFMEA’s and Quality initiatives*Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.***What will you bring?*** Ability to draft complex protocols related to Experimental Design and Process Validation.* Attention to detail while maintaining the ability to multi-task and manage project timelines is essential* Good communication and interpersonal skills**What will you need to succeed?*** Undergraduate degree in Chemical or Mechanical Engineering is desired, but other relevant disciplines such as Biochemistry, Biomedical Engineering or Engineering Physics may be considered. M.Sc. would be considered an advantage, and/or an equivalent combination of education and technical experience acceptable to Epocal* Minimum of 3 years of related industrial experience* Experience with process development and validation in a regulated industry such as pharmaceuticals or medical devices, are both highly preferred* Experience with development of process control strategies is highly preferred* Experience with Risk Analysis and Root Cause Analysis tools is preferred* Demonstrated knowledge and skill in the use of statistical tools and application of statistical tools and application of statistical software programs (JMP, Minitab)**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:$72,000 - $103,000Factors 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.