Program Manager – Medical Markers

Title: Program Manager – Medical Markers
Last Updated: May 17, 2021
Location: Waterloo, Ontario (with option to Work from Home, Canada or US)
Reports To: Director, Manufacturing Operations
Expected Travel: 5%
Employment Type: Regular Full-time
When the world’s top medical device OEMs and academic institutes need real-time medical instrument navigation, they call NDI. Why? Because no one can rival the accuracy and reliability of optical measurement and electromagnetic tracking solutions. Since 1981 we’ve helped our customers bring tracking technology to image-guided surgery systems and interventions, surgical simulators, advanced medical research, and so much more. We’ve built our reputation on technical expertise, continuous product innovation, and a commitment to our customers’ success. Our home base is in Waterloo, Ontario, but our team members live and work all over the world. Interested in becoming a valued member of the NDI team? We’re growing and looking for great people to join us.
Role Summary/Purpose:
We are looking for an experienced Program manager to lead the day to day, and long term, success of our Medical Markers product portfolio. The Program Manager will own the tactical and strategic oversight of ensuring that the outsourced supply chain can achieve our customers goals for quality, delivery, and cost.
The Program Manager will be the point of contact for the NDI Leadership team and will interface with many departments, including marketing, product management, account management, purchasing, product management, engineering, quality, and external supply chain partners. This role is very broad and will be best supported by someone who has both the technical acumen and collaboration skills to lead projects between NDI Internal groups and external suppliers.
Scope of Responsibilities:

• Responsible for the overall day to day management of our outsourced partners to manufacture and deliver all product to support the medical markers demand plan and development road map.
• Collaborating with our suppliers to mitigate any short term or long-term technical risks that could impact our customer orders and continuity of supply.
• Coordination of demand and supply with customer care and purchasing teams.
• Material and Inventory review with suppliers to ensure security of supply to meet demand.
• Regulatory – Support customer documentation requests by working through others in QA to establish MSDS, 510k filings for new country or in country registration.
• Quality – Support Root cause analysis on customer complaints, manage CAPA and SCAR reports.
• Supplier Quality – Plans and conducts Quarterly Business Reviews with key suppliers that will include discussions on quality, delivery, capacity, cost, change management and process improvement.
• Engineering Change Management – Supplier coordination for the introduction of new SKU’s or changes to current product or process documentation.
• Coordinating internal teams to qualify new supplier processes, materials, or molding tools.
• Facilitating key Original Equipment Manufacturer (OEM) customer requests and customer change notifications. (ie. Material change management or process change management)
• New Product Development – Supports any development work on new disposable product concepts by working with suppliers to deliver samples.
• Responsible to maintain and develop the capabilities of current supply chain partners.
• Responsible to identify, qualify and develop new suppliers as needed.
• Lead Pricing negotiations and contract management discussions with current and new suppliers.
• Conduct supplier site visits as required.

Quality Requirements:
NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices and employees of NDI. Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold. Employees of NDI are instrumental to our compliance efforts and are required to understand and comply with the QMS.

• Responsible for meeting quality assurance standards while making sure that all product specifications and manufacturing procedures comply with ISO 9001, ISO 13485 and the US FDA Quality System.

Education and Professional Qualifications:

• Project or Program management experience in a high-tech industry, preferably medical device, plastic molding & assembly, or custom packaging.
• Experience collaborating with outsourced manufacturing partners & product development teams.
• Sc. in Mechanical Engineering, Material Sciences Engineering, Project Management or related discipline.
• Responsible to be the advocate for the Marker product line across the organization.
• Ability to balance priorities effectively across multiple product lines and manufacturing locations.
• Effective at functioning with a high level of autonomy in setting objectives, influencing decision makers, managing expectations along with budget and resource allocation.
• Inclusive communicator who can effectively communicate project status to stakeholders, ensuring appropriate review and support with key stakeholders.
• Collaborative approach to problem solving and process improvement.
• Engineering and technology background to collaborate with highly technical teams.
• Passion for delivery high quality products from ideas to finish designs released to production.

Desired Characteristics/Additional Assets:

• Medical device experience (ISO 13485).
• Experience with consumable product manufacturing and product sterilization techniques.
• Experience with Project Management.

Why NDI:

• Exciting and challenging work based on cool technology.
• Stable company that genuinely respects the life-work balance.
• Generous employer-paid benefits package.
• Casual work environment.
• Company-wide bonus program.
• Employee stock purchase plan.
• Employee social and engagement events throughout the year.
• Holiday shut-down.
• Free onsite parking.
• Growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
• Close to GRT and ION stops.
• Located just off the Conestoga Expressway, close to Conestoga Mall, the St. Jacobs Farmers’ Market, and other retail amenities.

Being a Part of our Team:
When you walk through our doors, you will find an open-concept office that promotes collaborative teamwork and fresh ideas. We enjoy tackling new challenges and developing new pathways to serve our customers. We are looking for innovative, hard-working individuals who don’t see this as just a job, but as a career choice. If this sounds like you, our HR team would love to hear from you. Follow the instructions below to submit your application.
We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.

Job Type: Full-time