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.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.

What you will do

The Senior Biocompatibility Engineer will represent the Global Manufacturing organization as a key member of biocompatibility support team. This role will be working closely with the biocompatibility SME to ensure an effective global biocompatibility program. The position will also focus on leading biological evaluations and special process validations (cleaning, packaging, endotoxin) efforts for new and commercialized product maintenance. This position can be based out one of the following Stryker locations: Bloomington, MN, Memphis, TN, Columbia City, IN or Mahwah, NJ.

Responsibilities:

* Plan and evaluate cleaning, biocompatibility studies and special process validations in support of implantable medical devices.
* Review, evaluate, interpret, and apply internal and external guidance documents as they relate to cleaning, and biocompatibility.
* Make positive contributions, recommend approaches and support updating/ developing procedures.
* Develop technically sound protocols, reports, regulatory summaries, and verification of methods and results in collaboration with global manufacturing sites, test laboratories and suppliers.
* Identify and analyze materials, design and process problems to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.
* Responsible for identifying critical process factors and their effects on biological safety.
* Develop and execute project plans to include definition of scope, timelines, critical path management, resources, and budgets.
* Interface with key business partners and represent biocompatibility support team on new product introductions teams.
* Generate, implement and maintain internal biocompatibility procedures and systems that comply with applicable global regulatory requirements.
* Lead and conduct biological hazards risk analysis.
* Responsible for identifying critical process factors and their effects on biological safety.

What you need

Basic Qualifications:

* Bachelors Degree in Biology, Microbiology, Science or a closely related field.
* Minimum 3+ years of experience of medical device, expertise in cleaning, biocompatibility, packaging, chemistry, special process validation and/or working in a lab.

Preferred Qualifications:

* Proven experience working with and understanding requirements for cleaning and biocompatibility with knowledge of relevant ISO (10993, 19227, 11737, 13485, 14971), ANSI, ASTM (F2459, F2847, F3127) standards and FDA Reprocessing Guidance is strongly preferred.
* 4+ years of experience of medical device, expertise in cleaning, biocompatibility, packaging, chemistry, special process validation and/or working in a lab.
* Possess knowledge and understanding of sterilization, cleaning, packaging and biocompatibility processes and contamination controls, principles, practices, and procedures of the field including ISO standards and compliance.
* Direct experience in biological evaluation of medical devices per ISO 10993.
* Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
* Knowledge and understanding of manufacturing contaminant and establishment of cleaning residue limits.
* Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams.
* Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
* Ability to interact at the highest professional manner with all organizational levels.
* Demonstrated ability to draw conclusions, present and make recommendations based on technical inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Design, Sourcing).
* Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute.
* constructively to a global team environment, outside departments and externally.
* Strong understanding of statistical techniques.