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Sterilization Specialist/Scientist - Job Opportunity at Bio Medical Device Company

Woodcliff Lake, United States
Full-time
Senior
Posted: April 4, 2025
On-site
USD 80,000 - 100,000 per year

Benefits

Comprehensive 401(k) retirement planning with competitive matching
Premium dental coverage for preventive and major procedures
Comprehensive health insurance package typical of large medical device firms
Flexible PTO policy enabling work-life balance
Vision insurance with coverage for preventive care and eyewear

Key Responsibilities

Lead development and implementation of microbiology and sterility assurance programs aligned with regulatory standards
Direct scientific research initiatives supporting product development and market expansion strategies
Manage cross-functional collaboration for new market launches including prototype assessment and registration testing
Oversee remediation projects and quality control programs ensuring compliance with FDA regulations
Develop and execute equity-building studies to enhance product portfolio competitiveness

Requirements

Education

University Degree in a Biological Science required (Masters/Ph.D. an advantage)

Experience

5+ years' experience in sterilization or microbiology for regulated products

Required Skills

Strong Microbiology understanding Working knowledge of FDA regulations Excellent communication skills (verbal / written) Ability to explain science to management Computer literacy (Outlook / Word / Excel) Ability to work on multiple projects Experience with Ethylene Oxide, Dry Heat, X-Ray or Gamma sterilization
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Sauge AI Market Intelligence

Industry Trends

The medical device sterilization industry is experiencing increased scrutiny due to environmental concerns around traditional ethylene oxide methods, driving demand for alternative sterilization expertise Growing emphasis on sustainable sterilization practices is creating opportunities for innovation in medical device processing Regulatory bodies worldwide are harmonizing sterilization standards, increasing the need for specialists who can navigate multiple compliance frameworks

Salary Evaluation

The offered salary range of $80,000-$100,000 is slightly below market for senior sterilization specialists in the Northeast US medical device sector, where comparable roles typically command $90,000-$120,000

Role Significance

Typically part of a specialized 5-8 person R&D Microbiology team within larger R&D organization
Senior technical position with significant influence on product development and regulatory compliance strategies

Key Projects

New product sterilization validation programs Regulatory submission support for novel medical devices Process optimization initiatives for existing sterilization methods Environmental impact reduction projects for sterilization processes

Success Factors

Deep technical expertise in multiple sterilization modalities Strong regulatory knowledge and interpretation skills Ability to bridge technical and business considerations Excellence in cross-functional collaboration and communication

Market Demand

Very high demand driven by expanding medical device market, increasing regulatory requirements, and limited pool of specialists with both microbiology and sterilization expertise

Important Skills

Critical Skills

Advanced microbiology expertise essential for developing and validating sterilization processes Regulatory knowledge crucial for ensuring compliance and successful product approvals Project management capabilities vital for handling multiple complex initiatives

Beneficial Skills

Experience with emerging sterilization technologies Statistical analysis skills for process validation Environmental impact assessment capabilities Quality management systems knowledge

Unique Aspects

Rare combination of both research and practical application in sterilization science
Direct involvement in new product development from concept to market
Opportunity to influence industry standards and practices

Career Growth

Typical progression to director-level role within 3-5 years given strong performance and business impact

Potential Next Roles

Director of Sterilization Sciences Senior Manager of R&D Principal Scientist Global Sterilization Technical Leader

Company Overview

Bio Medical Device Company

Mid-sized medical device manufacturer with focus on skin antiseptics and sterile medical devices

Established player in medical device sterilization with growing market presence
Strategic Northeast US location with proximity to major medical device and pharmaceutical clusters
Professional R&D environment with emphasis on scientific rigor and regulatory compliance
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