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Rapid Micro Biosystems Manufacturing Engineer II in Lowell, Massachusetts

Manufacturing Engineer II will have responsibility for day-to-day manufacturing floor support and for the development and implementation for manufacturing systems for new products. This includes supporting the evaluation, analysis, and implementation of projects driving Safety, Quality, Delivery, and Cost Improvements to manufacturing processes. Activities include product and process design and characterization for manual and automated processes, equipment design (User Requirement Specifications URS), vendor management, equipment & operation qualification (IQ/OQ/PQ), and equipment and process implementation. Solve problems through root-cause investigation skills (process excellence methodology). Will be accountable for the appropriate execution of process development activities at internal sites and external suppliers. Prepare technical reports, project updates, and status reports for the team and senior management. Additionally, this position requires problem-solving skills and technical knowledge (Lean, DMAIC) and managing complex projects to a successful and timely conclusion.

This individual will be responsible for the design, development, implementation, and sustaining of the manufacturing systems that produce a product for RMB. Responsibilities will also include other upstream activities such as capital equipment, facility requirements, existing and emerging manufacturing technologies, tool design, cost estimating, and configuration control. This individual will work closely with others to complete initial prototype builds, analyze results, and refine engineering designs.

ROLES & RESPONSIBILITIES:

  • Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality

  • Evaluation and troubleshooting of production equipment and manufacturing process

  • Work with Quality and Customer Support counterparts to address manufacturing nonconformances and customer complaints

  • Generate and modify manufacturing process documentation

  • Identification of cost reduction (yield improvement or other) opportunities and perform an assessment based on impact and effort for prioritization.

  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

  • Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve the process and first-pass yield.

  • Understand manufacturing and problem-solving concepts like Value Stream Mapping, 5S, A3, and DAMIC to improve quality, labor efficiency, throughput, and ensuring the root cause of the problem is identified and quickly resolved.

  • Oversees the development of production and process control information, prepares technical analysis, recommends manufacturing methods and processes required to meet design objectives on new or improved products or processes.

  • Design, develop, implement, and validated manufacturing process and equipment for new product developments.

  • Responsible for product impact assessments, sampling, plans, technical reports, and technical evaluations, rationales, and approval for engineering and process changes and documentation pertaining to process development, qualification, and validation to meet requirements.

  • Drive concurrent engineering starting at the beginning of the product lifecycle.

  • Drive Design for Manufacturing/Assembly/Quality/Cost (DFM/A/Q/C) activities and process specification definition throughout the product development lifecycle.

  • Responsible for design and characterization of prototype equipment and pilot processes in support of manufacturing scale-up.

  • Support identification and qualification of suppliers for specialty materials, finished goods, and equipment.

  • Support root cause investigations and manufacturing process improvements.

  • Support 3D modeling and tolerance analysis

  • Support/perform design reviews, FMEAs, risk/hazard analysis & establishing technical requirements.

  • Support successful setup and transfer of scaled production processes.

  • Support the debugging of production processes and equipment.

  • Helping to identify production-scale equipment.

  • Set up pilot-scale production lines.

  • Drive system changes including work instructions, standard operating procedure, and business systems.

  • Complete the validation of equipment and processes as required (IQ, OQ, PQ, PPQ).

  • Support facilities layout changes and improvements for new product developments

  • Perform training for new and existing processes.

  • Work with suppliers as necessary to ensure quality, resolve technical issues, and improve processes or products.

  • Build reliability into Operations equipment and processes.

  • Establish risk analysis processes to increase reliability.

  • Identify, evaluate, and implement new process technologies in alignment with business objectives.

    EDUCATION & QUALIFICATIONS:

  • Bachelor?s Degree in Engineering or applicable field

  • 2+ years of manufacturing engineering experience required.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with the ability to effectively communicate at multiple levels across different shifts in the organization.

  • Be able to work independently without supervision, multitasks, prioritizes, and meets deadlines promptly.

  • Strong organizational and follow-up skills, as well as attention to detail.

  • Ability to travel approximately 10%, including internationally.

  • Ability to maintain regular and predictable attendance.

  • Understand engineering principles theories, concepts, practices, and techniques.

  • Ability to manage multiple projects and responsibilities simultaneously.

  • Ability to effectively troubleshoot manufacturing processes.

  • Highly collaborative

    UNIQUE SPECIAL REQUIREMENTS & SKILLS:

  • Medical device or heavily regulated industry experience preferred.

  • Robust technical skills with a proven application on projects

  • Experience with Minitab or other statistical software

  • Equipment and process validation experience

  • Experience with high volume automated equipment and systems

    WORKING CONDITIONS/PHYSICAL DEMANDS

  • Must be able to read and write English.

  • Close visual acuity to work on a computer and to determine the accuracy, neatness, and thoroughness of work.

  • Appropriate gowning procedures will be required for access to the cleanroom (hairnet, safety glasses, cleanroom apparel/lab coats, gloves)

  • Occasional environmental odors may be present.

    SPECIAL NOTICE: How do we protect our employees from COVID-19?

    Our Lowell facility is fully CDC compliant and as well we follow the State of Massachusetts and local guidelines. At Rapid Micro Biosystems employee health & safety is our top priority. We have implemented and maintain precautions to prevent the spread of COVID-19 at our facility. We provide masks, appropriate PPE gear, and hand sanitizer to all essential employees who must report to work. Before entering the facility, employees have their temperatures checked. In addition, we take great care that all frequently touched surface areas are sanitized throughout the day, as well our facility is fully cleaned daily.

    About:

    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 Directthe 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 Lowell, Massachusetts, with operations in Lowell and Freising, Germany.

    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.

    Please no phone calls or agencies please.

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