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Technical Specialist - Product Development jobs in United States
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Medicom Group · 2 months ago

Technical Specialist - Product Development

Medicom Group is a company with over 35 years of experience focused on creativity and customer satisfaction in the medical device industry. They are seeking a Technical Specialist to support product design and development, ensuring compliance with global regulatory standards and contributing to the successful execution of design control and process improvement initiatives.
E-CommerceHealth CareMedical

Responsibilities

Execute product design and development tasks supporting Medicom’s United Medical Enterprise (UME) contract manufacturing operations and NAM Product Development objectives
Support new product development and sustaining engineering projects from concept to commercialization
Participate in design control activities: specification definition, verification & validation, design reviews, labeling development, and risk management
Support design transfer and continuous improvement initiatives across manufacturing sites
Ensure compliance with medical device standards and regulations including CMDR, FDA QSR, ISO 13485, CDC NIOSH, and EU MDR
Support regulatory audits (FDA, notified bodies) and remediation projects related to design control documentation

Qualification

Design controlProduct developmentRegulatory complianceContinuous improvementTechnical developmentRisk managementSpecification definitionVerification & validationCollaboration

Required

Bachelor's degree in Engineering, Science, or related technical field
Minimum of 2 years of experience in a regulated medical device environment (R&D, Quality, Compliance, or Regulatory)
Strong understanding of design control and product development processes
Ability to collaborate in a multi-site and contract manufacturing setting

Preferred

Master's degree or relevant professional certification
Experience in continuous improvement, design transfer, or regulatory audits

Benefits

Competitive compensation and growth opportunities within a global organization

Company

Medicom Group

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Founded in 1988, the Medicom Group is one of the world’s leading manufacturers and distributors of high-quality infection control, single use and preventive products for the medical, dental, industrial, veterinary, laboratory and health and beauty markets.

Funding

Current Stage
Late Stage
Total Funding
$57.34M
Key Investors
Strategic Innovation FundInvestissement Quebec
2023-12-01Grant· $53.34M
2020-04-28Grant· $4M

Leadership Team

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Lucia Cao
Global VP Sourcing and Strategic Partnership
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Company data provided by crunchbase