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.

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.

As a member of the Sequencing Cartridges MSAT (Manufacturing Sciences and Technology) team, this role is responsible for technical and logistical aspects of critical business projects from planning to implementation and launch. 

MSAT is a matrix organization and this role acts as a subject matter expert in DQM (design for quality and manufacturability) and Product Transfer topics to facilitate deliverables with our MSAT and Operations colleagues. As a representative for MSAT, this role drives Technical Operations topics and any resolutions with project stakeholders related to DQM and Product Transfers working in cross-functional and multinational teams and projects. 

Provide guidance, issue resolution, escalation for Technical Operations topics and act as a conduit to the program leadership team on critical business projects in a matrix organization. Partners with Leadership and Business Stakeholders to help define and drive the Operations strategy for DQM (design for quality and manufacturability) and Product Transfers.

Participates and gives input to process risk assessments, facilitates CTQ (critical to quality) definition, and scorecard exercises to ensure process controls are in place and process capability has been documented.

Participates in specification development and reviews guard band data. 

Participates in process development to align with manufacturing site capabilities.

Informs and facilitates manufacturing site process development in partnership with Manufacturing site representatives and MSAT Engineering teams as needed.

Facilitates design transfer activities to internal and external manufacturing sites.

Proactively determines operational needs for projects and communicates to appropriate functional groups. Other duties as assigned by management

Who You Are

You have a Bachelor’s Degree, BS/BA degree or equivalent in Engineering or relevant sciences.

You have 5 years Medical Device or In Vitro Diagnostics industry experience

Experience in manufacturing, quality, product or process engineering,

You have strong written and verbal communication skills. Demonstrated capability to interface effectively with customers, management, and staff.

Preferred Qualifications

You have 8 years Medical Device or In Vitro Diagnostics industry experience

Demonstrated project management skills

Design Transfer, Technical Transfer, or product launch experience for complex consumable products (molding, assembly, electronics design/assembly)

Experience with next generation sequencing (NGS), Instrument, or Consumable design controls and transfer.

Experience developing, executing, analyzing and documenting robust multivariate experiments (DOE) and statistical data analysis (using statistical software such as Minitab or JMP) is a plus.

Experience evaluating assembly tolerances, part design, material selection, and manufacturing methods. Solidworks or similar design/modeling software experience.

Experience drafting requirements, facilitating assembly, buy-off, and characterization of custom process equipment a plus.

Process development and characterization a plus.

 Are equivalencies acceptable?

Yes Equivalent combinations of education and/or experience are acceptable

Knowledge, Skills and Abilities 

Ability to work with all levels of management and build relationships across disciplines

Comfortable around all levels of staff and management; maintains a confident stance, stays focused and on-point, and is able to raise problems or challenges in a productive and competent manner.

Demonstrate skills in assessing, summarizing and presenting business or operational priorities and decision-points for effective, timely and efficient management/executive decision-making.

Strong partnering and collaboration skills; has exceptionally strong and highly effective working relationships with manufacturing teams preferred.

Strong influencing skills; achieves targeted results without authority by leveraging his/her expertise, knowledge, interpersonal skills, organizational savvy and relationships preferred. 

Able to work independently with minimal supervision preferred.

Relocation assistance is available for this opportunity

The expected salary range for this position based on the primary location of Indiana is $84,500.00 - 156,900.00 USD Annual.  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

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.