0650 Medical Device Engineer

Executive Summary:
Device Engineer III will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.
The candidate has technical expertise in ¬the development and commercialization of drug device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within the Company’s device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges. The Senior Device Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems.
The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members.
The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines.

Job Responsibilities:
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.

This objective will be accomplished by executing activities in the areas of:
Device Engineering:
Develop and commercialize devices including interfaces with the primary container.
Provide guidance and input regarding product development using structured product development process.
Regularly interface with staff and leaders in Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.
Regularly interact with external development partners and components suppliers.
Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in, and applying training materials for test methods.

Design Control:
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
Employ good document practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
Participate in hazards analyses and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.

Qualifications:
Education and Industry Experience:
B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on DOE, problem solving and modelling using physical rules.

Technical Knowledge:
Strong skills in relevant modeling, design controls and/or statistical analysis.

For example:
Engineering: Design controls, Electromechanical system design, System engineering, Testing fixture and procedure development, Root Cause Analysis.
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, Design for Manufacturability, Molding.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
Six Sigma (Green/Black Belt): DMAIC and DFSS.
Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses.

Interpersonal Skills:
Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
Excellent communication skills are required. Experience in working with external partners is also highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.

Compensation Range: $70 – $95/hr