Mechanical Engineer, Custom Consumables

General Electric Westborough , MA 01580

Posted 11 months ago

Role Summary:Join the GE Healthcare Life Sciences R&D Life Cycle Engineering group. Focus on engineering activities for custom applications of single-use fluid pathway assemblies for upstream and downstream processing of biologics based on direct customer input. Role requires the application of design, engineering, product testing, data analysis, report writing and task self-management skills to drive customization of multiple product lines, all while working in a cross-functional team environment.

Essential Responsibilities:
Support design of custom single-use products; components, assemblies, packaging, tooling and fixtures. Analyze and validate custom designs per user requirements to meet performance, cost, compliance and manufacturability targets. Leading product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD, tolerance stack analyses) to lead design decisions.

  • Create detail and assembly drawings, specifications and associated Bill-of-Materials.

  • Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.

  • Manage activity at external test facilities to complete verification activities.

  • Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.

  • Release products through the ECR/ECO process.

  • Coordinate project priorities with team and Product Managers.

  • Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.

  • Maintain a safe work area.

Qualifications/Requirements:
Bachelor's degree in either Mechanical Engineering, Plastics Engineering, BioEngineering.

  • Minimum 2 years of relevant experience in Mechanical engineering, Biological Sciences, Biotechnology, medical device development or a related field.

  • Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.

  • Experience in plastic part design and GD&T per ASME Y14.5 standards.

  • Knowledge of plastics and relevant material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.

  • Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.

  • Knowledge of materials, properties, Mfg. processes, and product assembly.

  • Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.

  • Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.

  • Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.

  • Hands-on experience designing, prototyping and testing of components and assemblies.

  • Strong communication and influencing skills and ability to gain buy-in for initiatives.

Desired Characteristics: Master's degree in either; Mechanical Engineering, Plastics Engineering or BioEngineering.

  • Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.

  • Experience in CAE analysis tools; FEA, CFD and MoldFlow.

  • Experience in leading projects/activities to meet customer requirements.

  • Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.

  • Leverages historical test data and applies engineering judgement to rationalize verification testing where appropriate.

  • Experience with sterilization adoptions.

  • Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.

  • Experience working in an Agile work environment.

  • Application of Risk Management methodologies to aid in meeting commitments

About Us:GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.


Additional Eligibility

Qualifications:
GE will only employ those who are legally authorized to work in the United States for this opening.Additional Locations:United States;Connecticut, Massachusetts, New Hampshire, Rhode Island;Westborough, Marlborough, Framingham, Hartford, Nashua, Providence;
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
R&D Mechanical Engineer

Danaher

Posted 2 weeks ago

VIEW JOBS 2/5/2020 12:00:00 AM 2020-05-05T00:00 Job Responsibilities: * Assumes engineering design authority for internal or external (outsourced) development activities by collaborating with Pall associates or third-party vendors that may be located on different continents. Ensures that product performance meets all specified requirements including regulatory (UL, ROHS, CE, USP VI, etc.) * Design and development of single-use, consumable products and associated hardware systems for biopharmaceutical manufacturing processes * Build CAD models and detailed manufacturing drawings of new products (Single-use assemblies, Hardware systems, Mixing devices, Storage tanks, etc.). * Drive good aesthetic and ergonomic designs * Present design concepts to Engineering, Marketing, and Sales through sketches, renderings, models, controlled drawings and reports * Assess the technical feasibility of concept designs through building and testing of prototypes or theoretical calculations and/or simulations. Writes test protocols to verify or evaluate design performance. Generates reports and presentations related to design activities * Documentation of engineering drawings, technical reports, and revision history, etc. using PLM (ECO, ECR) (follow good drafting standards, geometric tolerances, etc.) * Uses tolerance analysis and stress calculations for design analysis * Provides regular technical updates and project summaries to R&D management and other key partners * Ensures a safe and balanced work environment by following all company safety policies and procedures * Finishes the mandatory training assignments (Ethics, Intellectual Property, etc.) * Travel to vendor and customer sites for FAT/SAT support as projects require, but typically averaging 10% or less * Helps develop project plans, stage gate work, conducts design reviews, and anticipates project road blocks, delays and risks * Utilizes critical issue and communication techniques to tackle problems Skills and Knowledge: * Outstanding teammate, ambitious and perseverance in face of technical challenges * Data and process driven. * Displays strong written and verbal communication skills. * Communicates effectively with team members and next level leaders via presentations, reports, etc. * Exhibits skills in leadership, conflict resolution, and consensus building. Basic Qualifications: * Bachelors Degree in Engineering * Minimum of 3 years of experience as a design or mechanical engineer involved in new product development environment * Experienced in 3D CAD modeling. Experience with design of complex assemblies (For example, Sheet metal, plastic, electromechanical systems) * Experience working with external vendors (subcontractors) such as mechanical fabricators, material suppliers, etc. * Knowledge of common and specialty engineering materials * Proficiency in MS Office (Word, Excel, PowerPoint and Project). Preferred Qualifications: * Master's Degree in Engineering or related field. * 5+ years' experience as a design or mechanical engineer in a new product development environment. * Experience with design and development of bioprocessing or food processing equipment. * Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, ISPE, etc.) * Experience in design and development of electronics and controls for electromechanical systems. * Basic knowledge or experience with software development. * Experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry. * Collaboration skills in a fast-paced, goal-driven matrix organization. Pall is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here. Danaher Westborough MA

Mechanical Engineer, Custom Consumables

General Electric