Senior Mechanical Engineer

Description

Hybrid - MUST BE LOCAL TO USTO

Monday Wednesday Friday Remote

Tuesday Thursday On site 8am - 5pm flex / 7am- 4pm

EM FEEDBACK- Looking for a candidate who has not job hopped every 6-8 months and has a solid root cause analysis skills technical writing statistical experience CAD skills thinker problem solver etc

Mainly Mechanical Manufacturing Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron or any other Force Tester Keyence is a huge plus. Not so much candidates with QA/QE experience they are usually good with documents and statistics and not so much a problem solver or overall technical.

Job Summary

The Lead Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products devices primary container and secondary packaging components as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product process tooling or equipment introduction to improve product quality and reliability.

RESPONSIBILITIES:

bull Assure transfer of new combination product test methods to QC or manufacturing by developing six sigma processes and compiling all required documentation.

bull Implement projects per Combination Product Operations CPO and company procedures to ensure projects are completed on schedule and within established budget.

bull Apply core engineering principles to develop physical test methods for medical device and combination product systems.

bull Perform data analysis to support method development qualification validation and transfer

bull Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.

bull Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons i.e. quality reliability new product introduction cost saving.

bull Coordinate gauge and equipment development and delivery with selected contractors.

bull Ensure that qualification parameters are met for product assembly and performance requirements.

bull Support development of cost estimates for new processes gauges and equipment development used in generation of capital request documentation.

bull Generate procedures necessary to support department and new product equipment.

bull Provide expert training to individuals in the operation and maintenance of processes gauges and equipment introduced to the manufacturing department i.e. production operator mechanics process engineers.

bull Participate in and assume responsibilities of team functions as assigned i.e. Product Improvement Teams. Supervise work of support staff during development and manufacture of system.

bull Excellent communication written and verbal and organizational skills

bull Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables

bull Networks with manufacturing quality and regulatory organizations both internal and external to Amgen

bull Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.

bull Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently

bull Integrates partner/vendor timelines with Amgen timelines as appropriate

Basic Qualifications

Doctorate Degree OR

Master's Degree and 3 years of Engineering experience

OR Bachelor's Degree and 5 years of Engineering experience

OR Associate's degree and 10 years of Engineering experience OR

High school diploma/GED and 12 years of Engineering experience.

Preferred Qualifications:

bull M.S. or Ph. D. in Mechanical Aerospace Mechatronics Chemical or Biomedical engineering

bull Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment

bull Experience with managing technical teams including setting priorities and leveling resources

bull Technical writing experience

bull Spanish language skills preferred

bull Experienced with SolidWorks or other 3D-CAD software

bull Familiar with equipment and software IOQ

bull Experience with process characterization scale-up technology transfer experience pFMEAs and dFMEAs

bull Experience with change controls deviations CAPA

bull Experience with combination products and device regulatory requirements

bull Understanding of the six sigma process utilizing Minitab or other statistical software packages to solve statistical problems

bull Work history with cGMPs regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing

bull Experience with machine controls PLC HMI and vision systems

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.