Back to jobs
New

Director, Combination Product Development and Human Factor Engineering

Remote

This is a remote opportunity with occasional travel, estimated at less than 25%.

Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.

​​The Director, Combination Product Development and Human Factor Engineering is responsible for managing the development of new combination products including design, development, and human factor studies through design transfer into manufacturing. The individual should be involved in building Kaleo’s intellectual property portfolio development. The Director will support the senior leadership team with critical information to make informed decisions on the selection of key partners, risks, and identification of critical milestones (budgeting, R&D build strategy, etc).​ 

​​This individual will need to develop strong relationships with external partners to ensure completion of all aspects of device/drug development and support of Human Factor studies from planning to execution. Internal interactions with Business Development, Manufacturing, and Regulatory Affairs provide opportunities to expand knowledge and make an impact on business development and post marketing activities.​ Key relationships to this position include Regulatory Affairs, External Partners (Suppliers, CMO and CDMO), Legal, Supply Chain, and Manufacturing.

As Director, Combination Product Development and Human Factor Engineering you will:

  • Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485 
  • ​Lead and responsible for human factor engineering activities as per the regulatory guidelines
  • ​Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget
  • ​Execute Risk Management Programs and Analyses in accordance with Kaléo's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019
  • ​Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities
  • ​Help build Kaleo’s intellectual property portfolio
  • Manage project and program budgets and timelines effectively
  • Author and review regulatory submissions (as needed)
  • ​Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs​ 

A successful Director, Combination Product Development and Human Factor Engineering will demonstrate:

  • ​​Self-motivated and confident with excellent personnel management skills, organizational skills, analytical abilities, and problem-solving techniques
  • Strong technical abilities while being an effective leader
  • Must demonstrate initiative, exercise good judgment, and have the ability to achieve results through others
  • ​Strong analytical skills with the ability to creatively solve complex problems
  • ​Excellent verbal and written communication skills when interacting with internal stakeholders at all levels of the organization and external partners, facilitating strong working relationships
  • Focused attention to detail
  • ​Ability to work collaboratively and cross-functionally when opportunity arises while holding the team to high standards of excellence
  • Display a tenacity to move major initiatives forward with a focused effort and clear set of business goals
  • ​Adept at integrating input from various functional areas and bringing people together to achieve results​ 

To be considered for this position, you must have:

  • Bachelors, Masters, or PhD in a technical field related to Product Development or Industrialization (Biomedical Engineering, Mechanical Engineering, Material engineering, Systems Engineering preferred)
  • Patient centric drug/device combination product development experience
  • ​Minimum 10+ years of medical device development experience, with experience in managing external CMO’s
  • ​Experience in design controls, risk management and ISO 13485
  • Minimum 5+ years of managing human factor engineering studies (formative and summative)
  • Demonstrated record of accomplishments preferred (e.g., issued US patents, device concept to launch, approved drug/device combination products)​ 

Create a Job Alert

Interested in building your career at Kaléo? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Kaléo’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.