Staff Scientist Full-time

Staff Scientist

We are searching for the best talent for a Staff Scientist in San Angelo, Texas!

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, and more personalized treatments. Your outstanding talents will help patients on their journey to wellness.

Key Responsibilities:

• Be responsible for EO sterilization execution maintenance activities and serve as the first point of contact for technical inquiries from Ethicon Manufacturing.
• Plan, conduct, and direct engineering projects or studies, including complete projects requiring advanced knowledge of sterilization.
• Oversee daily sterilization operations, including review of deviations and corrections, trend assessments, and technical support for the sterilization process.
• Execute periodic qualifications and performance metrics for the sterilization process.
• Conduct validation of new processes and products, including performance qualification (PQ) and establishment of success criteria.
• Assess the impact of product and process change controls for sterilization.
• Conduct EO cycle and NPRT re-qualifications.
• Perform periodic product EO residual analysis.
• Participate on project teams by providing sterilization expertise to build internal knowledge and support business decision-making.
• Perform failure investigations and product impact assessments for non-conformances related to sterilization parameters.
• Lead or provide technical support for CAPAs related to sterilization issues.
• Serve as a contributing member of multidisciplinary project teams in the design, development, and manufacturing of surgical sutures, biosurgical applications, and medical devices.
• Apply comprehensive and diverse knowledge of scientific principles and practices within broad assignment areas.
• May coordinate and direct activities of technical support staff and support technical development of assigned staff.
• Track and trend data, identify opportunities, and implement process improvements to improve business measures.
• Investigate product inquiries and develop and implement appropriate corrective actions.
• Analyze data and complex situations involving evaluation of tangible and identifiable variables to arrive at creative and effective solutions.
• Exercise independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results on new assignments.
• May provide guidance and work direction to lower-level scientists and engineers.
• Serve as back-up signature authority for the Base Business Sterilization team.
• Comply with all applicable quality management system, environmental, safety, and occupational health policies, including ISO 11135, ISO 13485, ISO 14001, and OSHAS 18001.
• Communicate business-related issues or opportunities to the next management level.
• Follow all Company guidelines related to Health, Safety, and Environmental practices as applicable.
• Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties as assigned.

Qualifications

Education:

• A minimum of a Bachelor's degree in Science, Engineering, Biomedical, or an equivalent related field is required.

Experience and Skills:

Required:

• 4 years of relevant work experience is required.
• Experience within the medical device industry is required.
• Broad understanding of environmental control, packaging, and manufacturing process impact on sterility assurance.
• Thorough experience with sterilization processes, including Ethylene Oxide process knowledge.
• Proven experience in change control processes within a regulated industry, including development, implementation, and test method validation.
• Knowledge of ISO, FDA, and other regulated standards.
• Advanced computer skills, including Microsoft Office and software applications.
• Working knowledge of CAPA and non-conformance systems is required.
• Proficiency in project management leadership and technical expertise.
• Strong leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail, and effective interpersonal skills.
• Ability to work in a team-oriented environment that embraces change, risk, and flexibility.
• Demonstrated ability to work independently and within a team.
• Mastery of analytical skills and professional judgment required to resolve major technical issues.
• Ability to deliver effective management-level presentations, write formal reports addressing technical and business implications, and prepare project plans while identifying and understanding interrelationships among related disciplines and key activities.
• Knowledge of FDA, BSI, ISO, and GMP requirements.

Preferred:

• Experience with LIMS or ERP systems is preferred.
• Experience providing sterilization expertise on cross-functional medical device project teams is preferred.
• Experience supporting EO residual analysis, EO cycle re-qualifications, NPRT re-qualifications, and sterilization performance metrics is preferred.

Other:

• Role is based in San Angelo, Texas.
• Work schedule and travel requirements to be confirmed.
• This position requires compliance with all applicable federal, state, local, and Company regulations, policies, and procedures.
• For those who supervise or manage staff, this role is responsible for ensuring subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all necessary resources are available and in good condition, if applicable.