Solution Engineer

460w EPOCAL INC.; Canada; On-site; CAD 103,000 - 147,000; Full time

Benefits offered by this job

Flexible benefits plan

Defined Contribution Pension Plan

RRSP matching contributions

Competitive vacation and leave

Job summary

Siemens Healthineers AG is seeking a Solution Engineer in Canada to develop and execute process improvements and generate validation protocols and reports in a CGMP-regulated environment. You will lead development initiatives, apply statistics, and collaborate with engineering, operations, QA, and contractors to ensure robust processes.

Qualifications include a bachelor’s in Chemical or Mechanical Engineering (MSc preferred) and at least 3 years of related industrial experience; familiarity with

Qualifications

• Draft complex protocols for experimental design and process validation.
• Attention to detail with ability to multi-task and manage timelines.
• Excellent communication and interpersonal skills.
• Bachelor in Chemical or Mechanical Engineering; MSc advantageous.
• Minimum 3 years of related industrial experience; regulated industry experience preferred.

Responsibilities

• Develop and execute process improvements and generate validation protocols and reports.
• Lead process development and improvement initiatives.
• Implement robust process control methodologies for existing processes.
• Apply statistical methods to justify improvements and ensure reliability.
• Collaborate with engineering, operations, QA and external contractors.
• Organize execution of validation protocols and release of reports.

Skills

Protocol drafting

Process validation

Statistical analysis

Multitasking

Communication skills

Team collaboration

Education

Bachelor in Chemical/Mechanical Engineering

Masters preferred

Tools

JMP

Minitab

Job description

What will you do?

• 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.
• 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 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.

The expected compensation for this position is:

$72,000 - $103,000. Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits

• Flexible benefits plan
• Defined Contribution Pension Plan
• Registered Retirement Savings Plan matching contributions
• Competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements)

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.

Company culture:

We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in‑vitro and in‑vivo diagnostics to image‑guided therapy and innovative cancer care, is crucial for clinical decision‑making and treatment pathways.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.