Manufacturing Engineer II
We are seeking an experienced Manufacturing Engineer with a focus on automation equipment development, implementation and validation to join our Mobius Engineering Automation Team in Danvers, MA. Mobius Engineering is focused on the production of single-use biopharmaceuticals assemblies. This position is primarily responsible for providing innovative automated solutions to existing manual processes through collaboration with equipment suppliers and internal colleagues.
· Develop and write equipment documentation (i.e. VMP, URS, FAT, Equipment IQ/OQ/PQ, DOE, and SOPs) for appropriate equipment and systems within the guidelines of cGMP, internal policies and procedures.
· Review executed protocols and review / write final reports
· Perform equipment IQ/OQ/PQ and provide maintenance / troubleshooting support on automation equipment as required.
· Provide guidance for the safe installation, maintenance and troubleshooting of automation machinery and equipment.
· Work closely with operations to develop, coordinate, and implement technical training plans for employees.
· Train operators and Preventive Maintenance Technicians on new equipment and process.
· Develop, evaluate, improve and document mechanical assemblies used in the manufacturing processes.
· Design fixtures, tooling and conceptual mechanical layouts.
· Provide engineering support in operations to trouble shoot and resolve technical mechanical and electrical issues.
· Support company policies and procedures, goals and objectives, all regulatory and GMP requirements.
· Support LEAN initiatives as needed
Who You Are:
· High School Diploma or GED equivalent
· 5+ years of experience working in a medical device environment.
· Bachelor’s degree in Mechanical, Manufacturing or Electrical Engineering
· Experience in definition, design, development and implementation of production control systems for an advanced technology facility.
· Ability to prioritize and work on multiple projects
· Able to self-direct toward individual milestones as part of team projects with a strong sense of responsibility, urgency, and high energy with a positive behavior.
· Must be a self-starter and work with minimal supervision
· Strong communication and interpersonal skills, ability to collaborate across disciplines
Job Requisition ID: 208785
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Nearest Major Market: Boston
Job Segment: Medical, Medical Device, Healthcare