SunMed LLC
Senior Test Engineer, Grand Rapids, MI
SunMed LLC, Grand Rapids, Michigan, us, 49528
COMPANY SUMMARY
At AirLife, we are dedicated to improving the quality of every breath.
Excellence with Every Breath
is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!
POSITION SUMMARY
This position will lead and support the testing and validation of products as well as manage the equipment controls in our world class test lab facility.
POSITION QUALIFICATIONS
The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.
Knowledge:
Acquired through education, certifications, training, experience.
Knowledge of product qualification, testing equipment, and testing methods.
Knowledge of equipment control, maintenance, and calibration.
Knowledge of quality standards and regulations for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives and EU Medical Device Regulations, and Canadian Medical Device Regulations).
Experience with an electronic quality management system is preferable.
Familiarity with International Standards and procedures as applied to medical devices.
Skills & Abilities:
Working knowledge of CAD and the programming of computer controlled test equipment.
Familiar with ISO, ANSI, AAMI, ASTM standards for testing.
Familiar with Good Laboratory Practices.
Basic hand tool operation and use.
Use of precision measuring tools, i.e. calipers, micrometer, depth gauge.
Excellent written and verbal communication skills. (Proficiency in Microsoft Word and Excel.)
Ability to organize and present data in a clear and concise manner.
High attention to detail and efficiency with excellent organizational skills.
Successful management of multiple projects and responsibilities at any one given time.
Highly self-motivated.
Excellent time management and prioritization skills.
Active learning – understanding the implications of new information for both current and future problem solving and decision making.
Level of Experience:
The ideal candidate will have 5+ years of experience in engineering, quality, or manufacturing of products, medical device industry experience preferred, with a focus on product testing/qualification as well as the management of the equipment to complete the testing. 3+ yrs. of laboratory experience. Experience using laboratory tools/instrumentation including (calipers, micrometers, vision systems, tensile testers, etc). Additionally, they will possess working knowledge of other laboratory software and mechanical drafting a plus.
Level of Education:
Bachelor’s degree (Engineering or biomedical sciences degree preferred) or equivalent work experience.
Lean / 6S / 6 sigma preferred.
Travel:
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manage and prioritize the activities related to design verification and validation of medical device products.
Create, standardize, and continually improve testing methods related to product testing.
Own the process for equipment control, calibration, and preventative maintenance.
Ensure all calibrations and preventative maintenance is completed on time and without disruption to the users of this equipment.
Standardize and improve the processes for the calibration, control, and preventative maintenance for all equipment across a global manufacturing footprint.
Manage multiple projects and responsibilities ensuring all committed deadlines are met.
Work with key stakeholders to prioritize the existing and incoming projects appropriately.
Effectively communicate timelines and status of projects to the key team members across the organization.
Expert level understanding internal work instructions to carry out product testing under the direction of lab management or the test requestor, and will supervise testing to ensure compliance with good laboratory practices.
Expert in test laboratory test method development and can interface with other engineering departments to develop the physical design, setup, and ruggedness testing of new methods.
Will play a lead role in in writing and owning old and new test equipment use work instructions and ensuring that they are kept current.
Expert user of the quality systems, including equipment profiles, test methods, protocols. Will be exposed to and access design control documentation such as product specifications, user needs, etc.
Will lead the development and maintenance of laboratory processes. Will help drive compliance and changes as needed.
Expert in the administration and use of the laboratory information system. Will be responsible for interfacing with various departments to design and maintain testing projects in LIMS type systems for technicians to use to electronically collect data. Will be responsible for ensuring full lab compliance with LIMS utilization from project request, data entry, review, and results reporting.
Expert in NC (non conformances)/CAPA processes, can lead efforts to document root causes, and drive their closures.
Will be actively involved in stability management and testing.
Coordinates and schedules testing activity.
Will serve as lead resource in training of staff on equipment & test methods.
Will serve as lead resource for supplier & vendor qualification for calibration, staffing, and testing services in terms of project needs within time/budget requirements.
Will be interfacing with lab customers (test requestors) as an expert technical resource for the lab. This will include development of test methods, results, training, and project management in general, and to seek clarification and directions as needed.
Will serve as a technical interface to the laboratory regarding testing capability, project status updates, analysis of test results, and test results reporting.
Must understand and pursue customer satisfaction while remaining committed to impartiality and performing all testing in an unbiased manner.
Will serve as lead resource in participating in coordinating and executing internal audits and preparing for external audits.
May assist sample management coordinator, and contribute to the proper inventorying, storage, and disposition of test samples.
Will serve as a lead technical reviewer for most internal test methods. Can train and qualify new reviewers.
Expert level coordinating and leading of Lean / 6S / 6 sigma projects. Must set an example of maintaining a clean and organized workspace.
Expert at develop testing automation equipment / routines to simplify and expedite testing.
Lead role in pursuing the improvement of laboratory metrics, customer feedback, addressing complaints.
Expert level understanding of product specification and working with other departments.
Expert level understanding of external test methods (consensus standards, etc.), will evaluate their suitability for product testing, and will adapt them as necessary into internal company test methods.
OTHER RESPONSIBILITIES
Focus on achieving our Company mission.
Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
Contribute to building and maintaining a positive team environment.
Assure all policies and guidelines are implemented and followed.
QUALITY POLICY
At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.
DEIA STATEMENT
At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.
#J-18808-Ljbffr
At AirLife, we are dedicated to improving the quality of every breath.
Excellence with Every Breath
is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!
POSITION SUMMARY
This position will lead and support the testing and validation of products as well as manage the equipment controls in our world class test lab facility.
POSITION QUALIFICATIONS
The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.
Knowledge:
Acquired through education, certifications, training, experience.
Knowledge of product qualification, testing equipment, and testing methods.
Knowledge of equipment control, maintenance, and calibration.
Knowledge of quality standards and regulations for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives and EU Medical Device Regulations, and Canadian Medical Device Regulations).
Experience with an electronic quality management system is preferable.
Familiarity with International Standards and procedures as applied to medical devices.
Skills & Abilities:
Working knowledge of CAD and the programming of computer controlled test equipment.
Familiar with ISO, ANSI, AAMI, ASTM standards for testing.
Familiar with Good Laboratory Practices.
Basic hand tool operation and use.
Use of precision measuring tools, i.e. calipers, micrometer, depth gauge.
Excellent written and verbal communication skills. (Proficiency in Microsoft Word and Excel.)
Ability to organize and present data in a clear and concise manner.
High attention to detail and efficiency with excellent organizational skills.
Successful management of multiple projects and responsibilities at any one given time.
Highly self-motivated.
Excellent time management and prioritization skills.
Active learning – understanding the implications of new information for both current and future problem solving and decision making.
Level of Experience:
The ideal candidate will have 5+ years of experience in engineering, quality, or manufacturing of products, medical device industry experience preferred, with a focus on product testing/qualification as well as the management of the equipment to complete the testing. 3+ yrs. of laboratory experience. Experience using laboratory tools/instrumentation including (calipers, micrometers, vision systems, tensile testers, etc). Additionally, they will possess working knowledge of other laboratory software and mechanical drafting a plus.
Level of Education:
Bachelor’s degree (Engineering or biomedical sciences degree preferred) or equivalent work experience.
Lean / 6S / 6 sigma preferred.
Travel:
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manage and prioritize the activities related to design verification and validation of medical device products.
Create, standardize, and continually improve testing methods related to product testing.
Own the process for equipment control, calibration, and preventative maintenance.
Ensure all calibrations and preventative maintenance is completed on time and without disruption to the users of this equipment.
Standardize and improve the processes for the calibration, control, and preventative maintenance for all equipment across a global manufacturing footprint.
Manage multiple projects and responsibilities ensuring all committed deadlines are met.
Work with key stakeholders to prioritize the existing and incoming projects appropriately.
Effectively communicate timelines and status of projects to the key team members across the organization.
Expert level understanding internal work instructions to carry out product testing under the direction of lab management or the test requestor, and will supervise testing to ensure compliance with good laboratory practices.
Expert in test laboratory test method development and can interface with other engineering departments to develop the physical design, setup, and ruggedness testing of new methods.
Will play a lead role in in writing and owning old and new test equipment use work instructions and ensuring that they are kept current.
Expert user of the quality systems, including equipment profiles, test methods, protocols. Will be exposed to and access design control documentation such as product specifications, user needs, etc.
Will lead the development and maintenance of laboratory processes. Will help drive compliance and changes as needed.
Expert in the administration and use of the laboratory information system. Will be responsible for interfacing with various departments to design and maintain testing projects in LIMS type systems for technicians to use to electronically collect data. Will be responsible for ensuring full lab compliance with LIMS utilization from project request, data entry, review, and results reporting.
Expert in NC (non conformances)/CAPA processes, can lead efforts to document root causes, and drive their closures.
Will be actively involved in stability management and testing.
Coordinates and schedules testing activity.
Will serve as lead resource in training of staff on equipment & test methods.
Will serve as lead resource for supplier & vendor qualification for calibration, staffing, and testing services in terms of project needs within time/budget requirements.
Will be interfacing with lab customers (test requestors) as an expert technical resource for the lab. This will include development of test methods, results, training, and project management in general, and to seek clarification and directions as needed.
Will serve as a technical interface to the laboratory regarding testing capability, project status updates, analysis of test results, and test results reporting.
Must understand and pursue customer satisfaction while remaining committed to impartiality and performing all testing in an unbiased manner.
Will serve as lead resource in participating in coordinating and executing internal audits and preparing for external audits.
May assist sample management coordinator, and contribute to the proper inventorying, storage, and disposition of test samples.
Will serve as a lead technical reviewer for most internal test methods. Can train and qualify new reviewers.
Expert level coordinating and leading of Lean / 6S / 6 sigma projects. Must set an example of maintaining a clean and organized workspace.
Expert at develop testing automation equipment / routines to simplify and expedite testing.
Lead role in pursuing the improvement of laboratory metrics, customer feedback, addressing complaints.
Expert level understanding of product specification and working with other departments.
Expert level understanding of external test methods (consensus standards, etc.), will evaluate their suitability for product testing, and will adapt them as necessary into internal company test methods.
OTHER RESPONSIBILITIES
Focus on achieving our Company mission.
Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
Contribute to building and maintaining a positive team environment.
Assure all policies and guidelines are implemented and followed.
QUALITY POLICY
At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.
DEIA STATEMENT
At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.
#J-18808-Ljbffr