Senior Manufacturing Engineer

Senior Manufacturing Engineer About US At Vyaire, we help the world breathe easier.
As a global leader in respiratory care, we know what we do enables, improves and extends lives.
We are a young company with a long history of revolutionary products.
We devise extraordinary solutions that allow patients to lead ordinary lives.
We believe the best way to create value for our customers, is to become invaluable.
We know a dynamic culture with diversity of thought makes this possible.
Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen.
We are dedicated to anticipating what’s next and get it done.
We thrive on contributing and making a difference.
To learn more, visit our website: www.
vyaire.
com Watch our video: https://www.
youtube.
com/watch?v=ZDrQoMbMRrI&feature=youtu.
be The Impact You'll Make in the Role.
As a Senior Manufacturing Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
Essential Functions: Working interactively with a cross-functional team and may be expected to lead multidisciplinary projects supporting organizational initiatives.
Being a key technical contributor in a complex environment of engineering projects working on industry leading technology.
Serving as an expert in electromechanical assembly, process optimization, and change management .
Working interactively with a cross-functional team, understand user needs, translate needs into manufacturing requirements and verify process output meets process input.
Actively participate in cross-functional meetings, projects and trainings to support operations and service.
Participate in stage gate process and ensure product design incorporates design for manufacturability Responsible for product transfer into and out of manufacturing locations for new products, acquisitions or to support business requirements.
Proactively identifies opportunities and develops, tracks, and communicates project plans to deliver process, product performance improvements and lean manufacturing concepts.
Interprets internal/external business challenges and recommends best practices to improve products, processes or services.
Builds and improves manufacturing core competency of the company, processes and customers by incorporating latest methods and manufacturing technologies into manufacturing platforms.
Identifies activity and assignment criticality and adjusts priorities when appropriate.
Pursue continuous manufacturing improvements by researching, benchmarking, attending conferences and staying current with manufacturing processes.
Understand, maintain, and update risk management documentation (i.
e.
pFMEA) associated with various manufacturing processes and use information to evaluate product impact of changes.
The role is expected to recommend data to collect, provide analytical support needed to analyze a problem, situation or issue, and provide guidance on next steps to achieve resolution of the issues.
Allocates appropriate amounts of time for completing projects; avoids scheduling conflicts; follow timelines and milestones.
Works hours necessary to complete assigned tasks.
Facilitate, review, and execute quality plans, equipment qualifications, process validations, and design control validations to support implementation of new manufacturing processes.
Perform validation execution and post-launch support of new products including identifying and documenting failure modes, the frequency of failures, and participating in root cause investigations.
Understands and knows the engineering processes and initiates, reviews and approves them to implement changes to production documents such as drawings, bills of materials and procedures.
Incorporate new and innovative work processes and ideas into daily work, demonstrating awareness and support of operational excellence initiatives.
Required to spend time learning the manufacturing assembly and process of the product lines.
Comply with applicable FDA and international regulatory laws/standards Comply with all CAL-OSHA rules and regulations Work within GMP, (Good Manufacturing Practices) Comply with the Vyaire Code of Conduct Other duties as assigned or required Your Skills and Expertise To set you up for success in this role from day one, Vyaire is looking for candidates who must have the following qualifications: 3+ years related work experience in medical device manufacturing Class II or Class III Engineering bachelor's degree required; Conceptual and practical knowledge of lean manufacturing tools and experience.
Experience in ISO 13485 and 21 CFR Part 820 quality systems in a manufacturing environment.
Sets a cooperative tone within the work group and across groups to get the work done Disciplined approach to define problems, data analysis experience, and the ability to summarize complex information for presentation to others and executive leadership.
Creates relevant options for addressing problem and achieving desired outcome Additional Qualifications that could help you succeed even further in this role include: Lean Green Belt or Black Belt certification Project management body of knowledge (PMBOK) SolidWorks Certification (e.
g.
CSWE, CSWP, CSWA, etc.
) for mechanical design Being someone who isn’t afraid to push the status quo, can work well with cross-functional teams, serve as an expert in design for manufacturing, and mentor and share expertise with colleagues.
Maintains high work and ethical standards, works collaboratively with others despite pressing deadlines and does work right the first time.
Proven Influence with internal/external business and/or regulatory issues that have an impact on the business.
Demonstrated knowledge of Manufacturing Engineering principles and technologies supporting production delivery targets and supporting gross margin improvement projects Leveraged process knowledge or subject mater expertise to identify opportunities/solutions to improve manufacturing platforms.
Developed into a role recognized as a contributor within the company and provide technical support to other departments.
Contributed to the Creation of an inspiring workplace.
Travel: up to 10% of time Relocation Assistance: May be authorized.
Benefit elections are among the most meaningful choices that we make for ourselves and our family.
That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees.
Base range in California for the Senior Manufacturing Engineer position is [$78,000 to $117,000].
Additional benefits offered include medical, dental, vision, paid leaves, life insurance, 401k, paid time off, paid holidays and potential for tuition reimbursement.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.
g.
, H1B status).
Coachella, CA, La Quinta, CA, Palm Desert, CA, Palm Springs, CA, Riverside, CA, San Diego, CA Full time