Aktivax, Inc. Senior Product Development Engineer in Broomfield, Colorado
Aktivax is a Specialty Pharmaceutical company developing and commercializing drug products in a portfolio of proprietary prefilled delivery devices, emphasizing improved usability, safety and drug stability. Our highly scalable Specialty Pharma model is based on a minimal core internal development team, supported by consultants and manufacturing subcontractors. Our leading development program is an emergency auto-injector for medical countermeasure treatment.
We look to develop products and treatments that improve the lives of the communities we serve. Our mission is to bring peace of mind to individuals and their communities through the work we do. Our vision is to be recognized for our innovative solutions that care for patients and communities. Our values are Truth, Goodness, Caring and Perseverance.
We emphasize a safe, inviting and inclusive culture. We are striving for a combination between a demanding and challenging work style and promoting a balanced life for our employees. We expect people to work hard, but we also encourage play (skiing on good snow days, meeting after work for pool, morning smoothies). We want you to bring your whole self to work. Our values are central to our culture and we believe that every position in this company will help lead us to greater innovation.
The Senior Product Development Engineer provides mechanical designs, develops, and documents medical devices using design control procedures in accordance with applicable regulatory standards.
Responsibilities and Duties
Designs medical devices utilizing Computer-Aided Design (CAD) software.
Performs engineering analysis including tolerance analysis, stress analysis, kinematic analysis, analyzing test results, and similar.
Documents engineering drawings and technical reports to ensure reliability and meeting regulatory standards.
Prototypes different components within the device to create alternative conceptual solutions to improve on the component and overall product functionality.
Tests and inspects components and assemblies.
Sources and interfaces with suppliers through technical communication and design documentation to obtain appropriate materials to develop custom prototypes.
Presents designs and interfaces with all levels of the organization and external customers and develops presentations and communications based on the receiving audiences? specific purpose.
References quality system manuals and relevant standard operating procedures (SOPs) and other external design guides to determine and ensure appropriate engineering design.
Develops Design Inputs (specifications, risk assessments, hazard analyses) to meet device requirements
Documents Design Changes to provide traceability and design history of the device
Performs verification activities to demonstrate that the requirements have been met, including developing test procedures, sample size selection, data analysis, and reporting conclusions.
Other duties as required and necessary to ensure the success of the organization.
Bachelor?s degree in Mechanical Engineering or other close discipline is required.
A minimum of eight (8) years of experience in device product development with the use of CAD software is required.
Specific CAD, SolidWorks or similar design software is preferred.
At least five years of experience in a medical device product development is preferred.
An equivalent combination of education and experience may be substituted on a year to year basis.
Ability to consistently promote, support, work, and act in a manner in support of Aktivax?s mission, vision and values.
Strong understanding of Engineering concepts, engineering drawings, technical documentation, and mathematical calculations.
Knowledge of medical device design and prototyping, including the use of basic machine shop equipment, mechanical testing, stress analysis/FEA (Finite Element Analysis), tolerance analysis, and design for manufacturing.
Strong working knowledge of statistical analysis techniques.
Strong working knowledge of mechanical engineering, product design and plastic part design.
Excellent written and oral communication to be able to explain the process for making a choice or decision and for resolving problems.
Ability to recognize problems and take prompt action to resolve them.
Ability to recognize what additional information about a problem should be collected.
Ability to distinguish between symptoms and causes of problems (root cause analysis).
Strong skill in the use of analysis software (Excel, Mathcad, Minitab, Matlab, python, etc.) and MS Office suite.
Strong interpersonal skills to resolve conflicts in resource allocations.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to:
Stand, sit, walk, talk, reach with arms and hands; bend, stoop, kneel and reach to install computer equipment, use hands and fingers to operate a computer and telephone keyboard, handle or feel, perform repetitive tasks/motions, hear alarms/telephones/normal speaking voice.
Specific vision abilities required by this job includes close vision requirements due to computer work, Light physical effort required by handling objects up to 20 pounds occasionally and/or up to 10 pounds frequently.