Job Title: Manufacturing Engineer – Medical Device Job Function: Engineer Location: Colorado Springs, CO
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM Life Sciences is seeking a Manufacturing Engineer to support the production of disposable medical devices, such as laser atherectomy catheters for peripheral and coronary procedures, support catheters, and lead removal tools. This position does both daily sustaining and project work to optimize production safety, quality and output.
Primary Responsibilities
• Develop solutions to safety or ergonomic concerns, which may involve analyzing work methods, developing fixtures or identifying new ways of doing a task.
• Daily sustaining work includes troubleshooting and developing solutions for various chemical and mechanical issues, especially with respect to the following: epoxies – mixing/ curing/ drying/ wicking/ polishing; plastic tubing – fusing/ 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 modeling – Solidworks, and more.
• 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.
• Organize investigations, pursue a logical course of inquiry, be able to collect and analyze data and see patterns/trends, analyze the results to fully understand root cause and implement solutions that will prevent reoccurrence.
• Use process thinking and lean tools to develop standard work, eliminate waste at the bottlenecks and simultaneously increase productivity, quality, safety while lowering costs.
• Training less experienced personnel on established methods and procedures. Facilitating the transfer of technical knowledge, while demonstrating an understanding of those with a diverse background or experience.
• Communicating fully with management and others who have a need to know. Being informative and communicating in a way that is timely, concise, clear and accurate.
Qualifications
2-3 years of Solidworks experience as a daily user.
Process validation and exposure to regulated environments and associated requirements.
Lean Manufacturing experience highly desired.
Standard work and Line Balancing within Lean Manufacturing is a must.
Education & Certifications
BS in Mechanical Engineering or similar discipline preferred.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Salary/Hourly Rate Range (W2): USD 35.00 – 45.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part time employees, who are at least 21 years of age, are eligible to participate in USDM’s 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM’s rewards and recognition program.
For more details about our benefits, visit us here: http://www.usdm.com/careers