Senior Staff Process Engineer (MSAT)

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Are you passionate about leading innovative engineering projects and elevating product quality and robustness? We are seeking a Senior Staff Process Engineer to join our dynamic team, where you will spearhead critical process engineering investigations, identify failure modes, and implement cutting-edge methods to enhance our ePlex products.

In this role, you will drive process development, characterization, and improvement activities for both new and existing product lines. Your expertise will be vital in designing and implementing new automation equipment, assessing production for quality enhancements, and validating new or improved processes and manufacturing equipment. You will work with advanced processes including surface treatment, precision dispensing of fluids and adhesives, and other sophisticated material sciences technologies such as plasma treatment, CO2 cleaning processes, and laser bonding.

Your strong communication skills will enable you to interact effectively with key decision-makers across various departments, including quality assurance, research and development, and manufacturing. Join us as we bridge the lines of communication, foster innovation, and elevate our products to new heights.

The Opportunity

• Continuously improve production processes in manufacturing

• Lead project teams as part of product improvements, automation, and quality improvements

• Troubleshoot issues that arise within the manufacturing process

• Lead or participate in teams to identify critical product or process attributes and parameters, design studies to characterize parameters (DOE), and evaluate risks and mitigations (pFMEAs/dFMEAs)

• Apply standard project management tools and principles to ensure project success

• Serve as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence.

• Lead change control activities within cross functional departments

• Create and approve Product BOM's, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.

• Follow cGMP and ISO standards

Who you are

• Bachelors in Engineering, 15+ years related experience or MS degree in Engineering and 10+ years related experience depending on level, background and industry.

• Experience in designing/implementing manufacturing processes, equipment and fixtures.

• Project Management successes with expertise influencing key decision makers within a matrix environment.

• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.

• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.

• Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.

• Proficient using SolidWorks preferred.

• Experience with design transfer activities for medical devices is a plus.

• Experience designing/implementing automation equipment is a plus.

• Chemical - Familiarity with multi-step organic chemical purification is a plus.

• Material Science knowledge is a plus.

• Experience with surface treatment (i.e. plasma, CO2 cleaning), laser bonding and dispensing is a plus.

Skills - Technical

• Must be able to lead cross-functional teams in problem solving, development of improvement plans and root cause-analysis.

• Demonstrated ability to support product launches and provide technical support in troubleshooting and resolving tooling/equipment issues.

• Experience in DFM analysis for various manufacturing processes, e.g. critical to quality attributes/parameters, Failure Mode and Effect Analyses (FMEA)

• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions.

• Must be proficient in the use of computer software programs such as Word, Excel, Visio, PowerPoint.

• Proficient using statistical software such as MiniTab or JMP is a plus.

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $106,100 - $197,100 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

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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.