Principal Development Engineer

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today’s innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky’s the limit.

Careers at RMB are fast-moving, with the high growth you’d expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You’ll do more, learn more, and have the ability to make a profound impact on our business.

SUMMARY OF ROLE

Join our team of engineers and scientists using consumables, robotics, vision, machine learning, and AI to advance the state-of-the-art biological growth detection system.  Rapid Micro Biosystems (RMB) is looking for a Principal Development Engineer.  As a Principal Development Engineer, you will play a crucial role in designing, developing, and testing the next generation of consumables and microbial devices from concept to commercialization. You will work closely with cross-functional teams, including product management, quality, and manufacturing, to ensure that our products meet the highest quality, safety, and effectiveness standards.  The Principal Development Engineer will be part of the NPD leadership in researching, designing, testing, and validating engineering solutions appropriate to each project assigned. This is a full-time position.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

·         Drive innovation in product design, evaluation of new technologies, and methodologies to improve product performance, reduce costs, and enhance manufacturability.

·         Lead the design and development of new product development projects focused on automated microbial systems, consumables, and culture media

·         Lead and mentor a cross-functional team of engineers and scientists, guiding the design and development of complex systems and ensuring alignment with company objectives.

·         In partnership with manufacturing engineering and the microbiology teams, oversee the development of mixing processes and dispensing/filling techniques for different types of culture media

·         Conduct feasibility studies, risk assessments, and design verification and validation activities to ensure that product designs meet performance and safety requirements

·         Oversee the prototyping of new designs and systems and lead the testing and verification to ensure performance, reliability, and adherence to specifications.

·         Work in a cross-functional team of product management, sustaining engineering, and operations teams to ensure seamless integration and scale-up of design solutions.

·         Ensure designs meet relevant industry standards and regulations, including leading efforts to involve independent testing houses (e.g., Intertek) to meet international standards

·         Collaborate with the internal procurement team and external suppliers to source and evaluate new components, to optimize cost and delivery schedules.

·         Oversee the creation and maintenance of technical documentation, including schematics, test plans, and design specifications.

·         Utilize CAD software to create detailed design drawings, 3D models, and prototypes

·         Lead and participate in design reviews and provide technical expertise and recommendations to improve product designs and processes

·         Provide advanced troubleshooting for design issues, ensuring root causes are identified and addressed in a timely manner.

QUALIFICATIONS AND ABILITIES

·         Bachelor’s degree in Biochemical or Bioprocessing Engineering, Mechanical / Materials Engineering, , Biomedical Engineering, or a related field

·         10 years of experience in the design and development of products in a regulated industry with at least 3 years in a technical leadership role

·         Experience in the development of new products and manufacturing processes from biological materials

·         5 years of experience with a gated process that adheres to ISO and FDA standards

·         Experience with robotics and automated systems preferred

·         Proficiency in CAD software, SolidWorks preferred

·         Excellent problem-solving skills and ability to work effectively in a fast-paced, collaborative environment

·         Effective communication skills with the ability to present complex technical information clearly and concisely in verbal and written formats

·         Experience with design controls, risk management, and quality management systems

·         Demonstrated ability to manage multiple projects simultaneously and prioritize tasks effectively

·         Proficient in documentation, dimensioning, and specification writing

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·         Experience with system testing and design verification experience that includes setting up and conducting tests, data acquisition and statistical analysis, summarizing data, and writing reports

WORKING CONDITIONS/PHYSICAL DEMANDS

·         Primarily in an office and lab setting with occasional manufacturing setting

·         Sitting and standing using computers

·         Some travel required <10%

·         Ability to work nights and weekends on occasion to meet critical deadlines

ABOUT RAPID MICRO BIOSYSTEMS:

Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.

The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.

Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.

Rapid Micro Biosystems is headquartered in Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore.

Equal Opportunity:

Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.