Job Description
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make The Combination Product Development team is a dynamic, growing part of Kindeva Drug Delivery. We have recently opened a facility in Germantown, MD and are seeking talented team members to help us provide customers in each major drug delivery combination product segment with a comprehensive offering of market-ready combination product platforms and world-class development service capabilities throughout the product lifecycle.
As the Senior Engineer, Combination Product Development, you will drive development of certain new drug delivery devices. You will report to the Principal Engineer, Combination Product Development, and will provide technical input and subject matter expertise for combination products, specifically autoinjectors and/or alternative drug delivery devices.
This role will contribute to all development aspects including product and test method engineering, design, optimization, robustness, reliability for assigned projects. You may contribute to research, design, documentation, hand's-on testing, debugging, and smooth design transfer. You will also contribute to the development and management of our design controls deliverables.
You must have medical device or combination product development experience to be successful in this role. Combination product development experience is desired.
This is a unique opportunity to have a direct impact on delivering final product solutions to our partners, patients, and have direct impact on the overall success of the organization.
We are building a culture of individuals who embody our PRECISE Values and expect you to lead with personal responsibility, respect, excellence, transparency, innovation, commitment, and energy.
Role Responsibilities - Drive technical development of devices and combination products.
- Collaborate with internal departments and with external vendors and CDMOs to deliver combination product projects according to project goals, timelines, and budgets.
- Support cross-functional teams to collaboratively define and execute device and combination product process development and technology transfer activities.
- Responsible for Design History Files, Risk Analysis, FMEA, Device Master Records, Specifications, etc. on all combination products, sub-assemblies and components as required.
- Perform risk management activities
- Perform investigations and manage change controls for new or improved designs for components, subassemblies and top-line assemblies.
- Establish and maintain an understanding of current trends and emerging technologies in the area of combination products, specifically autoinjectors.
Basic Qualifications - A minimum of 4 years of pharmaceutical, device and/or diagnostics development
- BS required, MS preferred in engineering or relevant technical discipline including but not limited to biomedical engineering, mechanical engineering, or chemical/biochemical engineering.
- Product development experience in regulated industry.
- Able to apply engineering skills and practices to gather user requirements and translate them into technical studies/assessments for drug delivery systems for characterization or qualification.
- Effective self-starter, strong communicator and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
- Ability to work on-site in Germantown, MD.
- Ability to do domestic and some international travel [up to 25%].
- Proficient in CAD, working in SolidWorks, PTC, Inventor, or other.
- Ability to utilize rapid prototyping techniques to generate testing fixtures, design concepts, subassemblies, and full assemblies.
- Knowledge and experience in data analysis and statistics and providing recommendations and next steps.
- Ability to perform basic stack-up analysis.
- Ability to apply first principles thinking into solving problems, generating models, and effectively communicating to the greater team.
- Experience with troubleshooting and root cause analysis.
- Ability to generate technical drawings per ASME or ISO/DIN standards
Preferred Qualifications
- Experience in the development of autoinjectors, pre-filled syringes, or other combination drug delivery devices.
- Experience with Combination Product regulations and experience with auto injector design/function.
- Experience with plastic injection molding
- Strong knowledge of technical standards ISO 13485, ISO 11608, ISO 14971 and 21 CFR 820. Relevant combination product verification and validation experience utilizing global quality and regulatory standards.
- Experience developing drug delivery devices for emergency use.
- Experience developing drug delivery devices for military and/or first responder applications.
- Expertise in Design for Six Sigma and Critical Parameter Development & Management methodologies.
- Experience in statistical scenario modeling through use of Monte Carlo Simulation or other tools.
- Experience in other statistical applications for development including Design of Experiments, ANOVA, regression analysis, t-test, etc.
- Experience applying statistical tolerance stack-up
- Experience performing Finite Element Analysis (FEA) using static, dynamic, linear and nonlinear, CFD, thermal, Multiphysics, etc., in SolidWorks, Ansys, Abaqus, COMSOL, or other software.
- Experience generating testing fixtures and methodologies.
- Experience performing engineering tests per identified methods, performing metrology measurements using basic and advanced measurement tools.
- Experience using Python, MATLAB, C++.
- Experience in instrumentation design and assembly using electronics, firmware, software, and hardware
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short, or long term basis.
- Must have the ability to simultaneously multi-task across multiple capabilities, functions and manages competing priorities, including performing site and functional responsibilities, frequent e-mail and phone communications and attending multiple meetings and conference calls. Note: these activities may not be time bound to core hours or presence at the site.
- Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
#LI-onsite #LI-BM1
California residents should review our
Notice for California Employees and Applicants before applying.
Equal Opportunity Employer: Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
Other details - Job Family A - Development - Biomedical Engineering
- Job Function A - Development
- Pay Type Salary
- Min Hiring Rate $89,500.00
- Max Hiring Rate $118,750.00
Apply Now
Job Tags
Full time, Temporary work, Local area, Remote work,