• Sr Staff Scientist - Medical Device

    Astrix Technology (Essex County, NJ)


    Sr Staff Scientist - Medical Device

     

    Science & Research

     

    Essex County, NJ, US

    Pay Rate Low: 128000 | Pay Rate High: 184000

    + Added - 27/05/2025

     

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    _Our client, a world-leading medical device company focused on improving lives through innovative, consumer-centered solutions is seeking a skilled_ **_Sr Staff Scientist._** _With a global presence spanning 30 countries, this is your chance to join an industry trailblazer making a difference every day._

     

    **Location:** onsite in Harris County, TX or Essex County, NJ

    **Employment Type:** Direct-Hire

    **Salary:** $128K- $184K DOE

    **Travel Requirement:** ~10%

    Position Overview:

    We are seeking a Sr. Staff Scientist to lead the technical strategy and execution of our IVF department, which plays a critical role in supporting embryo development during vitro fertilization. This high-impact, visible role is key to driving innovation, product improvements, and global expansion within the Life Sciences division. This individual will manage initiatives across product development, method validation, risk assessment, and regulatory compliance.

    Key Responsibilities:

    + Lead the design and execution of product evaluations, analytical methods, and validation studies for IVF Media solutions.

    + Provide biological risk assessments and technical support to manufacturing teams for process development and optimization.

    + Manage R&D workstreams related to new product development, line extensions, and lifecycle improvements.

    + Contribute to the creation of technical documentation to support regulatory submissions, global market entry, and ongoing compliance.

    + Ensure scientific and technical rigor and enforce best practices across all research and development activities.

    + Develop and refine design input requirements and oversee the verification and validation (V&V) strategy.

    + Present key findings and project updates to senior leadership and executive stakeholders.

    + Build and maintain relationships with external collaborators, vendors, and consultants.

    + Ensure full compliance with design control standards, quality systems, and applicable regulatory requirements (e.g., ISO 10993, MDR/MDD).

    Qualifications:

    + Bachelor’s degree in Life Sciences, Biochemistry, Analytical Chemistry, or a related field required.

    + Advanced degree (Ph.D. or M.S. with 4–7 years of experience) strongly preferred.

    + Minimum of 10 years’ relevant industry experience, ideally within medical devices, pharmaceuticals, or biotechnology.

    + Direct experience with IVF Media or cell culture media development and manufacturing is highly advantageous.

    + Strong working knowledge of medical device regulations, including MDR/MDD, ISO 10993, and classifications for Class II/III devices.

    + Demonstrated hands-on proficiency in biochemical techniques, statistical methods, and experimental design.

    + Proven ability to lead complex R&D projects and drive them to timely completion.

    + Excellent problem-solving skills, with a structured and risk-based approach to decision-making.

    + Strong communication and interpersonal skills, with experience engaging stakeholders at all levels—from engineers to executives.

     

    _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_

    _\#INDBH_

    _\#LI-DNP_

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.