Oversee production of Transmedics Organ Care System Perfusion Sets.
Supervise team of production personnel responsible for producing Perfusion Sets. This includes hiring, developing, scheduling and directing employees, communicating expectations, managing performance and addressing questions or concerns.
Lead efforts to ensure all production and test related activities are executed in a timely manner to satisfy the Companys production schedule and quality standards (cGMPs, QSR and ISO requirements). Monitor the accuracy, completeness and timeliness of manufacturing processes.
Ensure Production team members are appropriately trained for assembly and test activities, as well as on company Standard Operating Procedures as required.
Identify opportunities to streamline production processes and remove inefficiencies through process, test and product design changes.
Support processes associated with manufacturing including material flow, inventory control and production documentation.
Develop and provide reports for key production metrics.
Ensure production areas are maintained in an orderly manner, production documentation is accurate and up to date and that production and test equipment are properly maintained and calibrated.
Work with Supply Chain, Quality and Production personnel to resolve component issues and expedite materials through the inspection and production processes.
Work with Technical team to identify and resolve technical and quality related issues identified in production.
Work with Engineering team to ensure TransMedics products are designed based on DFM, testability and post distribution serviceability considerations and that product adheres to performance, cost and quality requirements.
Support Facility related activities as required.
Perform other TransMedics tasks and duties as required.
Bachelor of Science in Engneering or Operations Management plus a minimum of 8-10 years experience working in a Manufacturing Environment.
Must have manufacturing experience in FDA/ISO regulated Medical Device/ Medical Equipment Industry.
Must be detail oriented with strong organizational skills.
Must possess strong leadership and interpersonal skills with willingness to be held accountable for deliverables.
Must have outstanding ability to communicate clearly and effectively.
Must have effective analytical and decision making skills.
A proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities is required.
Must have the ability to identify, prioritize and resolve issues as they arise with minimal supervision.
VIEW JOBS10/18/2019 12:00:00 AM2020-01-16T00:00ROLE SUMMARY
The clinical manufacturing manager is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
The successful candidate will lead a 2nd shift a team of 5-7 colleagues responsible for the operation, troubleshooting, and data analysis of microbial fermentation and purification processes.
Focus for the initial assignment is on the shakedown and start-up of two production suites and hiring of staff in support of microbial fermentation operations.
* Perform the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
* Responsible for in plant manufacturing operations, production support or process technology transfer to ensure the on time delivery of high quality drug substance for clinical use.
* Direct reporting and career development responsibility for a team of 5-7 engineers and/or technicians.
* Lead troubleshooting of manufacturing equipment and control systems. May perform operations as needed.
* Lead/Support the design and qualification of new equipment or system improvements, changes, or upgrades.
* Strong bioprocess knowledge required to provide guidance or direction for team and effectively communicate and/or escalate process related issues.
* Coordination of team activities and scheduling of operations with other area managers.
* Cross functional collaboration with BRD lab scientists, Quality Unit, site and network manufacturing facilities, and Engineering on interdepartmental and cross site initiatives.
* Lead team through product changeover activities
* Support all investigations and audits as needed.
* Provide off-shift and on call support when necessary.
* BS or MS in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent)
* 5+ years of experience in biologics process development, technology transfer, pilot or manufacturing required.
* Understanding of upstream/downstream cell culture and/or fermentation is strongly desired.
* Demonstrated capability to work across functional areas such as development, maintenance, quality and regulatory.
* Good communication skills, verbal and written, are required.
* Experience in a cGMP environment with increasing responsibility is desired.Management experience is also highly desirable.
* Working knowledge of automated production systems with ability to manipulate and troubleshoot systems.
ADDITIONAL OFFER DETAILS
* Last Day to Apply: November 15, 2019
* Additional Location Information: Andover, MA
* Eligible for Employee Referral Bonus: Yes
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
VIEW JOBS10/16/2019 12:00:00 AM2020-01-14T00:00TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.
TransMedics is developing new manufacturing process capabilities in support of current and next generation Organ Care Systems and is looking for a highly motivated mechanical engineer with demonstrated success designing complex disposable medical devices and implementing new manufacturing processes. A strong technical background, experience with injection molding, and SolidWorks modeling skills are required.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
* Responsible for new process development and implementation into clean room assembly environment.
* Interface with internal and external technical resources to develop components and sub-assemblies for the OCS Heart, OCS Lung and OCS Liver product lines.
* Improve component designs and processes for manufacturability.
* Implementation of designs and robust processes for injection molded plastic components.
* Perform injection mold validations and first article inspection protocols and reports.
* Develop drawings in accordance with applicable standards.
* Collaborate and communicate with cross-functional teams and leadership
* Perform other TransMedics tasks and duties as required
* At least 7 years of experience performing mechanical engineering for complex disposable medical device products.
* Expert in SolidWorks 3D modeling, standard analysis tools for fluid flow, mechanical detailing, tolerance analysis, and documentation
* Extensive experience in plastics injection molding and secondary operations.
* Strong background in process development, integration, and validation.
* Must be able to work in a fast paced, high energy, collaborative team with a strong sense of urgency.
* Strong written and verbal communication skills are required.
* Previous experience with automation integration is preferred.
* Previous experience working on Class II or III medical devices is preferred.
* Previous experience developing blood contacting disposables is preferred.
* BS in Mechanical Engineering, Biomedical Engineering or equivalent is required
MedicalDentalVisionShort Term & Long Term DisabilityLife InsuranceFlexible Spending AccountsCompany HolidaysVacation401(k)Transmedics Group, Inc.AndoverMA
VIEW JOBS10/11/2019 12:00:00 AM2020-01-09T00:00What does it take to make the world a safer place? It takes delivering innovative technology and collaborating with some of the finest talent in the engineering field. Whether you're a software engineer or a mechanical engineer, at Raytheon you'll grow a varied and rewarding career. And you'll be supported with a comprehensive and competitive benefits package that promotes work/life. If you're ready to take on today's big challenges, discover a world of opportunity at Raytheon.
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Raytheon Integrated Defense Systems Execution Operations (XOPS) is offering a great opportunity for a Continuous Improvement/Lean Specialist in the Advanced Electronics Subassembly (AES). The Advanced Electronics Subassembly team achieves Operational Excellence through the mindset and practice of continuous improvement. We are focused on delivering superior and affordable solutions for our customers. This position requires an "out-of-the box" thinker responsible for cell design, developing strategy for lean implementation tactics, driving lean projects across multiple manufacturing cells, and management/sustainment of Tiered Accountability Boards.
In addition to the above, responsibilities include, but are not limited to:
* Supporting deployment of control systems, tools and metrics to accurately measure progress and drive continuous improvement, as they relate to the work cell
* Area layout and flow management
* Executing capital projects
* Executing sustainable process improvement initiatives using Lean and Six Sigma tools to achieve cycle-time reduction, improved quality, and increased productivity
* Facilitating Lean Kaizen events and/or training
* Documenting/maintaining financial performance of lean initiatives, and safety/ergonomics programs
* Working closely with production Cell Leaders, Value Stream Leaders, cross business teams, and the Operational Excellence Resource Center
This position can be a Salary Grade G06 or Salary Grade G07 based on the candidate's qualifications as they relate to the skills, experience and responsibility requirements for the position
* Must be knowledgeable about lean manufacturing concepts such as six sigma
* U.S. Citizenship status is required as this position needs an active U.S. Security Clearance as of day one of employment.
* High computer literacy and with confidence and skill working with Microsoft Office Tools (Excel, PowerPoint, Project) and familiarity with Raytheon systems (VM, PRISM, PDM)
* Experience utilizing business systems and tools that aid in manufacturing and financial management
* Leadership experience in a manufacturing environment with knowledge of manufacturing planning/scheduling and operations
* Metrics driven and success oriented, Six Sigma Expert/Black Belt or Lean Certification
BA or BS degree or equivalent education and experience
What's YOUR Mission?
Here at Raytheon, we work together as one global team creating trusted, innovative solutions to make the world a safer place. Our innovation spans all domains: from land and sea to air, space and cyberspace. We're inspired by a noble mission that's shared by Raytheon employees around the globe and an inclusive culture that empowers employees and celebrates their contributions.
What We Offer: Whether you're just starting out on your career journey or are an experienced professional, Raytheon offers a robust total rewards package that goes above and beyond with compensation; healthcare, wellness, retirement and work/life benefits; career development and recognition programs. Some of the superior benefits Raytheon offers include parental leave, flexible work schedules, achievement awards, educational assistance and child/adult backup care.
Find out why Forbes ranks us among the top 500 of America's Best Employers by visiting us online at www.raytheon.com.
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Raytheon: Making the World a Safer Place
"Diversity is at the heart of all we do at Raytheon. We embrace diversity and diverse opinions; we treat people with dignity and respect to support our inclusive culture. This allows us to retain and attract the world-class talent and supplier base we need to develop the innovative solutions our global customers depend on. We view our diversity as a competitive advantage as a key enabler of our growth."
* Thomas A. Kennedy
Raytheon Chairman and Chief Executive Officer
Type Of Job
MA - Andover
Raytheon is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, age, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.