Sr Mechanical Engineer (PI)

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Reporting to the Manager, Production Irradiator Engineering, you will be responsible for the design, testing, commissioning, and on-going technical and manufacturing support of advanced automated industrial equipment (production irradiators).

You will work closely with cross-functional teams including Project Managers, Design and Drafting team, and the Production Irradiator Controls team to deliver projects on-time and on budget.

Key Responsibilities

• Apply in-depth knowledge of engineering principles and standards to solve complex design and implementation challenges
• Lead and provide technical leadership throughout the project lifecycle and in all aspects of the design and manufacture of irradiator components and assemblies. This will include leading in the design process, coordinating manufacture, performing safety analyses including engineering calculations, creating specifications, coordinating and executing testing; compiling results and generating reports, and providing input for continuous improvement
• Collaborating with customers and interdisciplinary teams to define clear and actionable technical requirements. Lead engineering design reviews to ensure they have met all the applicable engineering, quality, safety, and regulatory requirements
• Lead mechanical engineering projects and be fully accountable to meet defined budgets, schedules, and functional requirements
• Perform root causes analysis and use rigorous problem-solving techniques to identify and rectify field issues in a timely manner
• Perform risk assessments and implement effective risk mitigation strategies
• Stay current with the requirements for production irradiators for both dry and wet storage panoramic irradiators
• Provide mentoring and oversight for work produced by more junior engineers and students

Qualifications

Education: Minimum Bachelor degree in Engineering (Mechanical)

Experience: Minimum of eight years relevant work experience in mechanical engineering

Certificates: Professional Engineer designation or be eligible for accreditation as a professional engineer within 1 year.

Skills And Competencies

• Design and engineering analysis of mechanical systems and components
• Perform engineering analysis and calculations including but not limited to: structural calculations, mechanical stress, machine design and component selection, tolerance stack up, etc
• Design, testing, and troubleshooting of mechanical or electromechanical equipment
• Hands-on experience with equipment commissioning and field installations. Leading installation crews of engineers and skilled tradespeople
• Excellent verbal communication skills. You must be able to clearly explain complex technical, regulatory and compliance aspects to non-technical audiences
• Proven ability to exercise sound technical judgments on complex decisions falling outside standard practices and procedures. Ability to make sensible decisions quickly in demanding environments
• Experience providing technical recommendations, providing technical guidance to other engineers and to technicians, and providing review and feedback on technical items
• Effective and collaborative team player with strong interpersonal skills

The Following Aspects Would Be Considered An Asset

• Prior experience in nuclear industry or similar high-reliability or regulated environments
• Prior experience in the design, analysis, and manufacture of automated or industrial equipment (e.g., packaging, material handling, robotics, irradiation/processing systems, etc.)
• Competency in finite element analysis using ANSYS (or other) software tools
• Familiarity with welding and more specifically weld design, specification and qualification

Additional Requirements

• Occasional overtime to meet project requirements
• Travel requirements (10-90 days international travel requiring valid Canadian passport)

Training Required

• Must complete all required training and certification as a Nuclear Energy Worker

Sotera Health goes to market through its three best-in-class businesses – Sterigenics, Nordion and Nelson Labs. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.