Sr. Staff Systems Engineer

F. Hoffmann-La Roche Gruppe; Carlsbad (CA); On-site; USD 110,000 - 206,000; Full time

Job summary

A biotechnology firm in Carlsbad seeks a Sr. Staff Systems Engineer to work on advanced diagnostics. This role involves systems design, engineering practices for in-vitro diagnostics, and cross-functional collaboration. The ideal candidate will have extensive experience in R&D and a strategic mindset for innovation.

Qualifications

• Minimum 10 years Systems Engineering experience in R&D for IVD or medical device.
• Demonstrated knowledge of regulatory standards (FDA, ISO).

Responsibilities

• Accountable for complex projects involving technical knowledge in engineering.
• Drive systems engineering practices and facilitate decision-making processes.

Skills

Systems Engineering Principles

Requirements Engineering

Risk Management

Tradeoff Analysis

Configuration Management

Scientific Background

Education

Bachelor's, Master's, or PhD in Engineering or Biomedical Sciences

Job description

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.

The Position

We advance science so that we all have more time with the people we love.

GenMark, a member of the Roche Group, is dedicated to providing world-class solutions for multiplex testing, with enhanced features that contribute to Roche’s commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the world’s #1 provider of diagnostics, the Roche Group offers an unrivaled experience in developing and commercializing tests that enable personalized treatment strategies for patients.

Working in research and development, the Sr. Staff Systems Engineer will hold technical accountability on complex projects, utilizing technical knowledge both in engineering and assay development to apply to key decision making as well as drive systems engineering practices on projects. This includes defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs.

• You have a comprehensive understanding of the system lifecycle process, IVD microfluidics design, and molecular assay development, and are accountable for applying that broad knowledge and skill-sets from the field of Systems Engineering to the organization.

• You can research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for differentiation and creative ideas for innovation.

• You will work closely with cross-functional teams, including R&D, Marketing, Operations, Quality, and Regulatory to ensure alignment with organizational objectives and regulatory requirements.

• You will engage with business leaders and Voice of Customer (VoC) representatives to ensure that technical solutions align with customer needs and market demands; facilitating stakeholder discussions to prioritize features and enhancements.

• You will analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address technical hurdles.
  

Who You Are:
(Required)

• You have a Bachelor’s, master’s, or phD in Engineering, Biomedical Sciences, or a related technical field with minimum 10 years Systems Engineering experience working in an R&D organization within the in-vitro diagnostics or medical device industry.

• You have demonstrated knowledge of systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation

• You have a scientific background and assay development experience.

• You have demonstrated a strategic mindset: showing the interest in innovative technologies and understanding of the competitive landscape in IVD.

• You have experience working in a regulated environment: demonstrating familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.

Preferred:

• You have a deep knowledge in a specialty engineering skills like design for reliability, manufacturability, or usability.

• You have the experience to build authority and accountability within a team, with strong collaboration and communication skills.

• You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you have the ability to formulate and solve problems; you complete work in a timely, accurate and thorough manner
  

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.

This position is based in Carlsbad, CA.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Carlsbad, CA is $110,500 - $205,100. 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

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.