Description
Hi,
This is Rohini with SSI, We have an immediate opening for Manufacturing Engineer II with our Direct client. If you are interested please reach me with your Updated Resume
Title: Manufacturing Engineer II
Duration: 6months + (Possible Extension)
Location: Colorado Springs CO 80921
Comments:
- Our Client, has an opening for a Temporary Manufacturing Engineer II.
Description:
- What You Will Do: As part of the team, the Manufacturing Engineering position will be responsible for working in a cross-functional team sustaining and improving processes for medical device products meeting ASTM standards. The successful candidate will have experience in the medical device manufacturing and other product types that meet industry, customer, and regulatory standards. This individual will be part of a world class team unsurpassed in creating real solutions for our customers. You will also support all other applicable Manufacturing Engineer team needs.
- What You Will Learn: We attract and hire the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry. You will learn from our Engineers and subject matter experts, about all facets of state of the art medical device process validation.
- What You Will Become: A capable technical teammate with an understanding of relevant job related tools, processes, testing equipment and an expert in process validation. A highly influential driver who will be key in supporting our sustaining and production needs for high impact results helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.
Education/Experience Necessary:
- Typical experience required is 3+ years as an Engineer in a related field
- Bachelors of Science degree in an engineering discipline, preferably in Mechanical Engineering but may also be Chemical, Electrical, or Materials Engineering degree; advanced degree is preferred
- Preferred candidate will have effective working knowledge and experience with Project Management, Lean, Design for Six Sigma, Design for Manufacturing and Reliability (DRM), DOE, Process Control (SPC), process FMEA, validation/qualification, traceability, and process documentation.
- Statistical analysis skill set is required. Experience with JMP or Minitab software is a plus.
- A thorough understanding of process validation relating to medical device regulations is preferred
- Knowledge of Process Validation, IQ, OQ, PQ, PPQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA's QSR and cGMP
- Experience in Medical Device Industry is preferred
- Familiarity with the Agile Project Management Scrum methodology a plus
What Success Looks Like:
- The Manufacturing Engineering team is a dynamic group of individuals with diverse strengths working together to continuously deliver solutions to meet the needs of our production customers. Successful engineers on our team are intensely curious, able to dig deep for root cause, analyze objectively, draw logical conclusions and follow through quickly to deliver solutions. We seek passionate people with a positive mental attitude who can interact with ease within and outside our team to develop and deliver win-win solutions.
- Process validation and verification work is frequently required - knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a and a clear understanding of FDA's QSR and cGMP and a good grounding in statistics would be instrumental to success.
- We work with a diverse group of processes, including: epoxies - mixing/curing/drying/wicking/polishing; plastic tubing - fusing/extruding/flaring/forming/injection molding; fiber optics - drawing, coating, curing, winding, stuffing, polishing; equipment troubleshooting/repair - simple mechanical machines, temperature controllers, PLC's, HMI's, motion controllers, etc.; packaging and sealing pouches and trays; cleaning - ultrasonic, ionizers; testing - burst, tensile, leak, optical gauge, FTIR, DSC, SEM; CAD modelling - Solidworks, and more
- Frequently we must dig deep into problems to fully understand root cause and implement solutions that will prevent reoccurrence. The manufacturing engineer will be expected to organize investigations, pursue a logical course of inquiry, be able to collect and analyze data and see patterns/trends, design controlled experiments and analyze the results of those experiments to make rational conclusions about courses of action.
- The manufacturing engineering team is also leaning in heavily to the application of Theory of Constraints and Lean to our production processes. We highly value engineers who are able to use process thinking and lean tools to develop standard work, eliminate waste at the bottlenecks and simultaneously increase productivity, quality, safety while lowering costs.
- Our team uses the Agile Scrum methodology to set the course of our weekly work. Together with our customers, we prioritize the highest value solutions and then plan our work in 2 week sprints and work together to achieve what we commit to. This methodology is ideal for high output, energetic, lively, positive contributors who like to feel part of a winning team delivering just what the customer wants. We care deeply about our customers, both internal and external, and strive to continuously improve our products and processes. We are eager to find teammates who are excited by this atmosphere and the opportunity to make a big difference in the lives of patients!
Supervisory Duties:
- No supervisory duties expected in this role
Job Related Skills:
- Knowledge of job related tools, processes, testing equipment, and catheter production equipment preferred.
- Demonstrated history of fast learning for job related tools, processes, equipment required
- The ideal candidate is proficient in Word, Excel, Outlook, Solidworks, JMP or Minitab statistical software, Agile documentation management system, Maintenance Connection, and all other job related computer programs
- Detail oriented, well organized, strong verbal and written communication skills
- Self-motivated and creative