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Manufacturing Process Engineer

3 months ago

Suwanee, United States Femasys Inc. Full time

About Femasys, Inc

Femasys is a pioneering medical technology company dedicated to advancing women's healthcare through innovative solutions. Our flagship products, Femaseed and FemVue, represent cutting-edge advancements in the field of reproductive health, empowering both healthcare providers and patients alike. We are committed to revolutionizing the standard of care in fertility and gynecological procedures worldwide.


About the Role

The Manufacturing Process Engineer is responsible for supporting Manufacturing with engineering activities as required for product manufacturing and product manufacturing transfer from R&D to achieve efficient, economical, and timely production of Femasys’ medical devices, and to maintain the highest standards of quality with the objective of maximizing growth and profitability. Participate in the development of company-wide processes and systems that result in the effective execution of the company's business strategy.


Responsibilities

  • Participate as a member of the Manufacturing team to support engineering activities in both production and pre-production environments.
  • Review, evaluate and implement engineering and specification revisions in compliance with regulatory requirements.
  • Develop and maintain eBOMs (Electronic Bill of Manufacturing) within the ERP system.
  • Support long-term and short-term manufacturing goals and objectives.
  • Develop and review manufacturing performance indices, and complete action to address any variations excessive costs, material shortages, NCMR’s or other deterrent factors that have a negative impact on manufacturing throughput and/or product quality.
  • Support a culture focused on customer metrics and continuous improvement.
  • Support training of new department personnel and provide mentoring/ guidance to staff to ensure adherence to professional standards, SOPs, and overall corporate objectives.
  • Maintain quality and cost metrics and continuously search for cost savings through a variety of means, including lean manufacturing techniques and appropriate capital spending.
  • Prepare and manage department budgets, operational procedures, policies and protocols.
  • Ensure that appropriate FDA and ISO regulations are complied with relative to traceability, equipment maintenance and validation, facility cleanliness standards, as well as other relevant requirements.
  • Ensure workplace is conducive to productive and safe work environment and compliant with appropriate federal and state regulatory requirements.


Physical Requirements

  • Normal manufacturing environment.
  • Domestic and/or international travel may be necessary.


Minimum Qualifications, Education & Work Experience

  • Bachelor’s degree - Mechanical or Industrial Engineering
  • Minimum 3 years of demonstrated medical device or relevant experience in a controlled environment.
  • An entrepreneur with a roll-up your sleeves attitude expressed by directly executing day-to-day activities necessary in an early stage, high-growth company.
  • Experience with equipment installations, debugging, qualifications and process validation.
  • Must be a positive, self-confident, decisive team member who has excellent communication skills in both oral and written formats, as well as excellent listening skills with a proven ability to solve problems.
  • Absolutely ethical with image and style that generates respect and credibility.
  • Thorough knowledge of ISO and US (GMP) regulatory requirements related to the manufacturing of medical devices, and quality systems.
  • Proven success in a dynamic, rapidly scaling work environment, ability to maintain effective working relationships.


Preferred Qualifications, Education & Work Experience

  • Class III Medical Device experience.
  • Comprehensive knowledge and aptitude with MiniTab, SolidWorks, ERP/MES systems and facility monitoring systems.
  • Lean Six Sigma certification.


Equal Employment Opportunity Policy

Femasys, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.


This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.