- Provides extensive expertise in medical device regulations and standards. This includes providing specifications to meet external standards and evaluating design and verification activities for compliance with standards.
- Contributes to project/iteration planning and to planning at the program level to ensure compliance with external standards and guidelines.
- Provides rationale for application and supports design teams in creating evidence.
- Describes and commissions work packages for external service providers outside the development team, such as accredited laboratories and certification bodies.
- Establishes insights into the requirements and/ or results of external certification bodies (TÃV, CB, etc.) and authorities (FDA) and thereby contributes to the success of technical product development.
- Acts as a coach at the program level: possesses the ability to oversee elements of evidence for approval and certification packages for hardware, software and chemical components, and derive recommendations.
- developing (functional) safety test strategies for overall product system design with the goal to assess the (functional) safety requirements/specification & standard compliance of overall product system design from early concept stage until final solution
- performing functional safety tests and evaluation of results to assess the functional safety requirements/specification of overall product system design
- Bachelor's degree in Engineering, Biomedical Engineering or closely related discipline with 5+ years of progressive work experience in an appropriate engineering field, including medical device product development; work pursued in support of an advanced technical degree may be considered
- Significant accomplishments in product developments with a focus on compliance with external standards or comparable experience in regulatory content
- Experience in mandating & monitoring work packages at accredited labs and third party testing services
- Experience in a regulated product development environment is a must, MD/ IVD experience is strongly preferred
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Senior Engineer - Indianapolis, United States - Roche
Description
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The Position
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
Here at Roche Diabetes Care, you will be working on reliability, safety and effectiveness of our cutting-edge medical devices. It is a unique opportunity where passion for healthcare meets purpose. You will work independently and as an integrated team member under the direction of the Design Verification manager or a principal engineer. You will contribute as an expert in hardware/system development by translating requirements from international standards, regulations and guidance documents into product requirements.
The Opportunity:
Who You Are:
Preferred:
*This is a campus-based role in Indianapolis, IN. Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Indiana is $106,500 and $148,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
