COMPANY DESCRIPTION

SunMed is a respected North American manufacturer and distributor of one of the most comprehensive portfolios of consumable medical devices for anesthesia and respiratory care. For more than 40 years, SunMed has expanded their product offering by adding reputable brands such as Salter Labs, Ventlab, Ethox Medical, and Westmed. The SunMed family of brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind.

POSITION SUMMARY

This position will lead and manage the implementation of product line extensions, custom product configurations, and other product customer requests.

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

KNOWLEDG Acquired through education, certifications, training, experience.

• Knowledge of project management tools to successfully manage timelines and project open issues.
• Knowledge of quality standards and regulations for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives and EU Medical Device Regulations, and Canadian Medical Device Regulations).
• Experience with an electronic quality management system is preferable.

• Mandarin and/or Spanish fluency is a major plus.

SKILLS AND ABILITIES

• Excellent written and verbal communication skills
• High attention to detail and efficiency with excellent organizational skills
• Management of multiple projects at one time in an extremely fast paced ever-changing environment
• Highly self-motivated
• Excellent time management and prioritization skills
• Comfortable presenting to groups of all sizes on status of projects

• Active learning – understanding the implications of new information for both current and future problem solving and decision making.

LEVEL OF EXPERIENCE

• The ideal candidate will have at least 3 years of experience in engineering, quality, or manufacturing of products in the medical device industry, with a proven track record of successfully leading projects to on-time completion.

LEVEL OF EDUCATION

• Bachelor’s degree required and equivalent work experience

TRAVEL

• <10% travel may be required as needed

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

• Lead a cross-functional team in the creation and updates of private labeled and customer requested product offerings
• Work with manufacturing facilities located in Mexico and China in setting up the new products
• Own the process for new product line extensions/customs SKU’s and update the process as needed
• Determine project scope and timeline based on the project request
• Manage multiple projects at once including resource allocation
• Set the project completion expectation for sales/customer’s and deliver the product on schedule
• Work with key stakeholders to prioritize the existing and incoming project appropriately
• Support the engineering documentation creation for the custom and private label products

• Effectively communicate project status throughout the organization

OTHER RESPONSIBILITIES

• Focus on achieving our Company mission
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.

• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At SunMed, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At SunMed, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve.

We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.