Aktiv Pharma Group is hiring for a Manufacturing Engineer Manager. We are a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system.

The Manufacturing Engineering Manager plans, directs, and coordinates the activities of a team of engineers and technicians within the manufacturing engineering department that is responsible for designing and developing the manufacturing process of Aktiv Pharma Group’s novel, flexible film based, primary drug containers.

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skill-sets and these values to apply.

The compensation range for the Manufacturing Engineer Manager is $100,000 - $130,000 annually.

Aktiv Pharma Group offers a wealth of benefits to our employees and their families.

Employee Benefits Include:

• Medical Insurance (Cigna):
  • HDHP – Aktiv contributes the full monthly premium for the employee and their dependents.
  • Two additional premium medical plan options – Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Vision Insurance (Principal/ VSP Network)
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Dental Insurance (Principal)
  • Low Plan - Aktiv contributes the full monthly premium for the employee and their dependents.
  • High Plan - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Legal & ID Shield
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Spending Accounts (Rocky Mountain Reserve)
  • FSA
  • HSA
  • DFSA
  • LP FSA
• Ancillary Benefits (Colonial Life)
  • Accident
  • Group Medical Bridge
  • Voluntary Life AD&D
  • Disability
• 401k (Human Interest)
• Unlimited Paid Time Off
• Bi-Monthly Internet and Cell Phone stipend
• Fully Paid Membership for the employee and their dependents to Lifetime Fitness
• Fully stocked office kitchen – Health conscious and Vegan!
• Remote Work Options

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Guides engineering team to solve problems, continuous improvements, and make critical decisions based on data analysis and sound engineering principles.
• Apply knowledge and experience in polymer film processing and blister packaging to combine the right balance of established processes, and innovation to pragmatically meet development and commercial targets.
• Designs or oversees design of internally developed manufacturing systems through inception, build, characterization and qualification.
• Collaborates with other managers and leadership in a cross functional matrix to set and assess priorities across teams.
• Creates or oversees creation of User Requirements Specifications for equipment to be developed by outside vendors.
• Collaborates with outside equipment vendors to develop and build systems to meet the User Requirements Specifications.
• Assesses cost effectiveness and feasibility of manufacturing processes; makes and implements recommendations to reduce costs and improve efficiency.
• Supervises design and installation of tooling /fixturing on manufacturing systems, ensuring all work is performed accurately and according to quality and safety standards.
• Develops Standard Operating Procedures and other documents to formalize engineering activities in compliance with Aktiv Pharma Group’s Quality Management System.
• Assists the Maintenance Supervisor and/or other appropriate leadership with programs, activities, and responsibilities of the maintenance department.
• Performs other duties as assigned.

Supervisory Duties

• Recruits, interviews, hires, and trains new staff in the department.
• Oversees the daily workflow of the department.
• Provides constructive and timely performance evaluations.
• Handles discipline and termination of employees in accordance with company policy.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Strong supervisory and leadership skills.
• Ability to recognize problems, identify additional information about a problem that should be collected and take prompt action to resolve them.
• Preferred experience in blister manufacturing / equipment design or application of multi-layer polymer based thin films.
• Knowledge in multilayer films such as material properties and manufacturing processes thereof.
• Ability to develop complex ideas in new and undefined areas which impact a major segment of the organization.
• Expert knowledge of medical device design and prototyping, including mechanical testing, FMEA (failure mode effects analysis), DoE (design of experiments), tolerance analysis, and design for manufacturing.
• Refined understanding of Quality Systems requirements.
• Knowledge and ability to transfer information to staff regarding the tools used for prototype development used by the organization such as CAD and machine shop equipment.
• Ability to analyze, interpret and create statistics and data from tests and designs (root-cause analysis) and ability to change direction quickly.
• Well versed experience, understanding and ability to apply protocols in compliance with company policies and Current Good Manufacturing Processes (CGMP), United States Pharmacopeia USP and Federal Drug Administration (FDA) regulations.
• Able to perform written and oral communication to be able to communicate with other engineers to explain the process for making a product, choice, or decision and for collaboratively critiquing a design and resolving problems.
• Proficient writing ability and analytical ability to develop and deliver professional specifications, reports and processes for presentation to present to senior leaders, vendors and clients.
• Ability to lead a team to cohesively meet organizational standards and timelines.

Education or Formal Training:

• A Bachelor’s degree in Industrial Management, Mechanical Engineering or other close discipline is required.
• Relevant experience may be considered in lieu of a Bachelor’s degree.

Experience:

• At least five years of supervisory experience preferred.
• A minimum of ten (10) or more years of experience with automation manufacturing machinery design and the use of CAD software in a pharmaceutical or medical device industry is required.
• An equivalent combination of education and experience may be substituted on a year-to-year basis.

Additional Requirements/Licenses/Certifications:

• Must have reliable transportation.
• Valid driver’s license.

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