Mechanical Design Engineer

Job Description

The Mechanical Design Engineer leads the mechanical design and development of specialty equipment that supports API and final drug product manufacturing. This role owns projects across the complete product lifecycle, from early concept and feasibility through production release and ongoing product support, with a strong focus on regulated healthcare and life sciences environments.

Job Title: Mechanical Design Engineer

The Mechanical Design Engineer leads the mechanical design and development of specialty equipment that supports API and final drug product manufacturing. This role owns projects across the complete product lifecycle, from early concept and feasibility through production release and ongoing product support, with a strong focus on regulated healthcare and life sciences environments.

Job Description

The Mechanical Design Engineer leads the mechanical design and development of specialty equipment that supports API and final drug product manufacturing. This role owns projects across the complete product lifecycle, from early concept and feasibility through production release and ongoing product support, with a strong focus on regulated healthcare and life sciences environments.

Responsibilities

• Lead the mechanical design and development of specialty equipment used in API and final drug product manufacturing.
• Own assigned projects through the full product lifecycle, from concept generation and feasibility studies to production release and ongoing product support.
• Create detailed 3D models, assemblies, engineering drawings, and technical documentation using CAD software, preferably SolidWorks.
• Perform engineering analyses, including tolerance stack-ups, material selection, and design reviews to ensure robust, reliable, and manufacturable designs.
• Develop and refine prototypes, and support testing, verification, validation, and qualification activities to confirm design performance and compliance.
• Collaborate closely with manufacturing teams to optimize designs for production, assembly, reliability, maintainability, and serviceability.
• Ensure designs comply with applicable regulatory and quality standards associated with regulated industries, including medical device, pharmaceutical, GMP, and related requirements.
• Participate in risk assessments such as FMEA and design hazard analyses to identify, evaluate, and mitigate potential design risks.
• Apply design controls, validation processes, and documentation practices appropriate for regulated healthcare and pharmaceutical environments.
• Work cross-functionally with Quality, Manufacturing, Operations, and Regulatory teams to align design solutions with operational and compliance needs.
• Contribute to continuous improvement of design processes, tools, and standards in support of advanced nuclear medicine and radiopharmaceutical manufacturing.

Essential Skills

• Proven mechanical design experience delivering products through the full development lifecycle, from concept and design through testing, validation, and production.
• Strong 3D CAD design experience, preferably with SolidWorks, including creation of detailed models, assemblies, and engineering drawings.
• Experience designing specialty equipment, medical devices, or complex mechanical systems.
• Experience working in a regulated industry such as pharmaceutical, medical device, biotech, or a similar environment.
• Knowledge of GMP requirements and regulatory frameworks including FDA, Health Canada, and EMA.
• Understanding of design controls and validation processes in regulated environments.
• Familiarity with risk assessment methodologies such as FMEA and hazard analysis.
• Ability to perform engineering analyses, including tolerance stack-ups and material selection.
• Experience collaborating with cross-functional teams including Quality, Manufacturing, Operations, and Regulatory.
• 5+ years of relevant mechanical design engineering experience.
• Bachelors degree in Mechanical Engineering or a closely related discipline.

Additional Skills & Qualifications

• Experience supporting verification, validation, and qualification activities for equipment and systems.
• Ability to document designs, analyses, and test results clearly and accurately for use in regulated industry submissions and audits.
• Interest in collaborating within a highly specialized industry and learning from experienced subject matter experts.

This posting is for an existing vacancy.

Job Type & Location

This is a Contract position based out of Ottawa, ON.

Pay And Benefits

The pay range for this position is $50.00 - $65.00/hr.

Individual compensation offered for this position wi