ABOUT STRAUMANN
Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and tech-niques in our field, we have a tradition of doing more to advance dental regeneration, restora-tion and replacement, as well as patient care. Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape our future and create impact. Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovation.
Job Purpose
The Product Development Engineer SDIS (Straumann Dental Implant System) with a focus on Biomaterials plays a strategic and coordinating role in the development of Biomaterials for dental implant systems. The Development Engineer will work closely with cross-functional teams, including Product Developers, Product Designers, Manufacturing, Quality Assurance, Regulatory Affairs, Pre-clinical operations, and Clinical Evaluation, to ensure our product offerings' successful development and enhancement. The initial focus will be on biomaterials, with the opportunity to extend responsibilities to additional components within the scope of Straumann Dental Implant System products.
Main Tasks and Responsibilities
- Drive the design and development of Biomaterials from concept to commercialization.
- Evaluation of technical solutions and performance of feasibility studies.
- Evaluation of business opportunities that come along with design modifications.
- Translate user needs and standards into design.
- Coordination of verification and validation (V&V) activities.
- Coordination of design transfer activities.
- Support manufacturing in the ramp-up of new and existing products.
- Collaborate with cross-functional teams to ensure projects are executed within established timelines and budget constraints, taking into consideration the design control process.
- Drive the evaluation and validation of new materials and technologies to improve product performance and durability.
- Author technical reports, documentation, and presentations for internal and external stakeholders.
- Lead root cause investigations.
- Ensure that the Design History File (DHF) documentation is according to GDP.
- Provide expertise as a Subject Matter Expert in audits.
- Propose and evaluate technical solutions and performance of feasibility studies.
- Translate user needs (market inputs) or standards into design inputs (technical specifications).
Requirements
Education
- Bachelor's degree in mechanical engineering, microengineering, bioengineering, materials sciences, or a related field of study; MSc is preferred, an advanced degree is a plus, and may count as working experience.
- Other relevant qualifications are a plus (e.g., Lean Six Sigma, Design Thinking, etc.).
Experience
- 1-5 years’ experience in a related area such as medical device development or other highly regulated products.
- Experience in dental implant development is a plus.
- Knowledge in product development, manufacturing, and testing.
- Knowledge of applicable standards and regulations (MDR, FDA, ISO, ASTM).
- Knowledge of the design control process.
- Knowledge of medical device manufacturing processes (e.g., plastic and/or metal injection molding, machining, post processing).
- Knowledge of specific development tools (e.g., statistical analysis, FMEA, analysis of mechanical properties, etc.).
- Familiar with operating in a matrixed environment.
Personal Attributes
- You are team-spirited with a pragmatic, hands-on approach.
- You have strong analytical and problem-solving skills.
- You have strong interpersonal skills and customer focus.
- You are an entrepreneurial thinker and take calculated risks.
- You have good communication skills, both verbally and in writing.
- You have high personal and professional ethics and are willing to embrace Straumann’s Mission and Culture.
- Good command of the English language in speaking and writing; additional languages are a plus.
- Working place: Basel. Flexible working max. 2days of home office possible.
- Travel requirements up to 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: Switzerland : Basel
Travel Percentage: 0 - 10%
Requisition ID: 17785
