Sr Materials Engineer
The individual in this position will develop and execute the materials science and hazardous substances analysis of medical device products, supporting the regulatory submission of both implantable and non-implantable *** products. This individual will also support biological evaluations by completing deliverables like the TUV biocompatibility checklist. This person will work under general supervision, assembling current design documentation, providing gap assessments and strategies to remediate in accordance with international standards and European medical device regulations (e.g. REACH, RoHS, EU MDR, California Prop. 65, etc...).
Analyzes and researches materials used in existing product designs and their related fabrication and application processes. Applies principles of chemistry, physics, and material behavior to develop metallic, polymer, and composite material and processing specifications, fabrication and assembly processes. Develops, analyzes and applies material properties and design, processing and quality engineering specifications. Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications. May review and approve subcontractor material processing procedures.
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
Knowledge of materials and interactions with the body and environment. Knowledge of international and domestic regulations associated with biocompatibility and Hazardous Substances. Experience in a regulated industry. Materials Science knowledge with an emphasis on materials testing, processing, manufacturing and analysis.
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. May manage projects/processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
Requires a University Degree in Materials Science, Chemical Engineering, or Biomedical Engineering and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Experience in regulatory and device regulations for medical devices including biocompatibility and regulated materials
Effective verbal and written communication skills
Ability to work well in a team environment
The ability to work well under pressure
The ability to evaluate, prioritize and manage multiple activities
The flexibility to adjust work objectives to ensure the overall goals are met
Demonstrated problem solving and critical thinking skills
Technical understanding of the effect processing has on material properties and performance
Ability to correlate material properties with product performance and predict various failure modes
About the Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.