Job Description

Southmedic is known globally as an innovative, high quality Canadian medical device manufacturer. At Southmedic you will enjoy an open-minded culture that fosters individual growth and career development within a dynamic team. Southmedic believes in continually investing in our staff; allowing you to reach your full potential through ongoing training and development. You will engage with a team that values respect, accountability, and integrity.



We are looking for an Engineering Program Manager - Medical Device

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Southmedic is dedicated to providing innovative medical solutions with a commitment to quality and customer satisfaction. We are seeking a dynamic and experienced Engineering Program Manager to join our team.

Key Responsibilities:

Customer Engagement:

Act as the face of Southmedic to the customer, engaging with integrity and professionalism. Ensure customer requirements are addressed promptly.

Project Management:

Manage customer projects following best project management practices, focusing on scope, time, and cost. Develop comprehensive project plans, define scope, goals, and deliverables, and establish timelines, resource allocation, and budgets.

Manufacturing Documentation:

Ensure manufacturing documents (batch records, QPS, labels, etc.) are ready prior to product launch and reviewed by manufacturing for training and verification.

Validation and Risk Management:

Lead PFMEA, validations, and risk management activities. Create and implement validation plans, protocols, and procedures for new or existing equipment, processes, or systems.

Document Control:

Control and ensure the correct revision of customer documents (specifications, ATPs, artworks, etc.) is used.

Regulatory Compliance:

Collaborate with the Regulatory and Quality team to ensure products meet all defined standards. Adhere to relevant regulations, industry standards (e.g., FDA, GMP, ISO), and internal procedures.

Engineering Support:

Provide engineering support to production and maintenance, or make resources available to support. Provide direction to engineering associates and coordinate their training and development.

Validation Protocols:

Author and coordinate the execution of validation protocols supporting manufacturing processes. Perform tests to ensure equipment and systems meet predefined specifications and standards.

Issue Resolution:

Identify the causes of equipment failures or process deviations and recommend corrective actions. Evaluate test results to identify deviations from standards, assess performance, and determine root causes of issues.

Documentation:

Prepare detailed reports, protocols, and other documentation to support validation activities and demonstrate compliance. Maintain accurate project documentation, generate reports, and present project status updates to stakeholders.

Process Improvement:

Identify opportunities to improve project management processes, tools, and methodologies to enhance efficiency and effectiveness.

Technical Oversight:

Provide technical guidance and support to project teams, ensuring technical feasibility and addressing technical challenges.

Additional Duties:

Perform additional duties as assigned by management.

Skills and Qualifications:

Technical Skills:

Strong understanding of engineering principles, testing methodologies, and relevant industry standards.

Analytical Skills:

Ability to analyze data, identify trends, and draw conclusions from validation results.

Problem-Solving Skills:

Capability to identify and resolve issues related to equipment performance or process deviations.

Communication Skills:

Ability to clearly and concisely communicate validation plans, results, and recommendations to various stakeholders.

Attention to Detail:

Meticulous approach to documentation, testing, and analysis.

Organizational Skills:

Excellent organizational skills, good judgment, and strong problem-solving abilities. Ability to manage multiple validation projects, prioritize tasks, and meet deadlines.

Education and Experience:

Post-secondary education in engineering, program management, or a minimum of 5 years of relevant experience. Proficiency in Microsoft Project or similar project management software and Microsoft Office. PMP certification, previous experience in a regulated industry, MDSAP, and ISO 13485 are considered assets. Knowledge in plastic molding and SolidWorks is not required but desired.

Dimensions of the Position:

Possess a good knowledge of engineering, engineering document processes, and requirements. Act as a Southmedic representative to the customer.

Problem Solving Responsibilities:

Essential problem-solving skills to ensure efficient and quick repairs/setups. Capability to identify and resolve issues related to equipment performance or process deviations.

Skills & Experience:

Project Management Expertise:

Proven experience in project management methodologies, tools, and techniques.

Medical Device Industry Knowledge:

Familiarity with the medical device development lifecycle, regulatory requirements (FDA, ISO), and quality systems.

Technical Background:

A degree in a relevant field (e.g., engineering, biomedical) is often preferred.

Leadership & Communication Skills:

Ability to lead and motivate teams, effectively communicate with stakeholders, and manage conflicts.

Problem-Solving & Decision-Making:

Strong analytical and problem-solving skills, with the ability to make informed decisions under pressure.

Risk Management:

Experience in identifying, assessing, and mitigating project risks.

Budget & Resource Management:

Ability to manage project budgets and resources effectively.

What We Offer

Retirement Program

- Southmedic will match RRSP contributions in our program that employees can begin participating on their first day.

Benefits

- Our group benefit plan covers medical, dental, vision, and other health needs, including our employee assistance program.

Perks

- Southmedic employees enjoy a variety of perks and discounts from local corporate partners like fitness memberships, events, and more!

Education Reimbursement

- Our continuing education program provides financial assistance for training and education courses.

Engagement

- We hold a number of social activities during the year including BBQ's, giveaways, and employee activities.




Southmedic is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please advise the Human Resources Department.



We thank you for your interest in joining the Southmedic Team!



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