Lead Design Engineer
The Lead Design Engineer is responsible for the application of their specific engineering field, along with expanded knowledge of medical and business fundamentals, to support the research and development of new technologies, processes and products.
This unique role will be based in one of the top tourist destinations in Eastern Europe for approximately one year – Prague, Czech Republic.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Inform business leaders in support of pipeline development decisions
- Lead internal and external research activities
- Provide project leadership for cross-functional activities
- Interact and build relationships with physicians and/or clinicians
- Develop strong partnership with cross-functional team members
- Complete documentation of all project data
- Perform job functions in accordance with applicable GMP and ISO standards
- Comply with applicable FDA and international regulatory laws and standards
This position does not have direct employee supervisory responsibility, though the success of this position is determined by the ability to effectively collaborate and partner with team members.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The items listed below are representative of the characteristics that are necessary to perform in this assignment.
- High level of integrity and strength of character.
- Results-oriented -- focused on delivering results that exceed the company’s expectations.
- Learning agility and ability to adapt and adjust quickly based on emergent needs from the business.
- Exceptionally detail-oriented and high organizational skills.
- Exemplifies servant leadership.
REQUIRED EDUCATION and/or EXPERIENCE
- Bachelor’s degree in Mechanical, Chemical, or Bio-medical Engineering, or related technical field; Graduate degree in a technical discipline a plus
- 3-5+ years of applicable work experience in an engineering role
- 3-5+ years' of experience in product development, R&D engineering, or related work experience.
- Understanding of medical device industry and competitor products. Working knowledge of other related disciplines.
- Demonstrated ability to take initiative in keeping current with technology developments in specialized area.
- Demonstrated knowledge and application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work.
- Effectively communicates and works cooperatively with others as part of a team. Shares information, status, needs, and issues with others in order to inform, gain input, and support decision-making.
- Knowledge of statistical process control in mass production as well as Six Sigma (DFSS) for design validation and optimization.
- Effective use of quality tools such as Design of Experiments, Statistical Process Control, hypothesis testing, regression analysis, Measurement Systems Analysis
- Excellent verbal and written communication skills
- Strong problem solving skills
- Medical device experience strongly preferred. Experience with medical device based products and technologies
- Basic clinical knowledge for uses of product – Hospital beds and surface areas, capital, etc.
- Knowledge of and ability to design reliable and innovative mechanical systems and mechanisms for consumer products.
- Knowledge of manufacturing processes including stamping, molding, machining, MIM and extrusions.
- Knowledge of clinical settings.
- ISO and/or cGMP certifications