Staff Engineer, Microbiology Job in Stryker

Job Description

Who we want:

• Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Persuasive influencers: People who understand market positioning and can use their relationship skill and depth of knowledge to secure buy-in, cooperation, and loyalty.
• Hard-working winners: Confident, competitive and results-oriented salespeople who create a track record of success.
• Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

• Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments.
• Playing a core part in development, review & approval of sterilization process & equipment also validation/qualifications (IQ, OQ & PQ).
• Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
• Participate in the development and improvement of the manufacturing processes for existing and new products.
• Support product transfers to other plants/facilities.
• Review/approve nonconforming material and system documentation.
• Review/approve product and process change control documentation and specifications.
• Actively participate on teams to support new product development activities.
• Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
• Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
• Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.

What you need:

• 8+ years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
• Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques.
• Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.
• Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.
• Experience with ISO 17025, Lab Quality Management System.
• Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
• Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
• Demonstrated ability to technically mentor associate engineers and scientists.
• Must understand the fundamentals of moist heat, gamma irradiation, and ethylene oxide sterilization.
• Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Experience in working in a compliance risk situation.
• Demonstrated experience with bio-compatibility tests, ability to interpret the associated industry guidelines.
• Prefer demonstrated competency in advanced testing technologies.