Back to jobs

Design Engineer

Remote / Richmond, VA

This is a primarily remote position and is open to remote applicants.

At Kaléo, our way is not to seek to be like others, but rather to passionately pursue meaningful and innovative solutions for patients. We believe all people should have access to the innovative healthcare products and solutions that empower each of them to live fuller, bolder lives.

Kaléo is pursuing development programs with pharmaceutical companies, with commercialization opportunities to follow. The Design Engineer will play a critical role in the successful execution of these development programs by working with the Director of Engineering and external collaborators to develop safe, effective products on-time and on-budget. The Design Engineer will play a key role in the management of external partners and collaboration with pharmaceutical partners in the delivery of these programs.

If you are a detail-oriented engineer with product development experience in the medical device industry, this is an exciting opportunity to work on life-transforming products while operating within a deadline-focused remote environment with clear objectives and milestones. The collaborative team setting will provide you with learning support while still fostering a high degree of autonomy and responsibility in your area of expertise. Kaléo’s “remote-first” hybrid culture will offer you the flexibility to choose your work location, placing an emphasis on self-management and adherence to deadlines. At Kaléo, you can feel confident that your work has a tangible impact on the lives of patients. 

As Design Engineer you will:

  • Conceptualize new product ideas by using Computer-Aided-Design (CAD) software to design prototypes.
  • Partner with the Director of Engineering, a key original member of the Kaléo team with over 200 patents issued during his tenure at the company on new delivery concepts.
  • Fabricate prototypes for testing, and test products throughout the design process to troubleshoot any potential problems.
  • Collaborate with external consultants and contract research organizations (CROs).
  • Apply Design for Manufacturing (DFM) principles to support transfer of the device from development into production.
  • Partner with the Documentation Specialist on Design Controls for new drug/device programs.
  • Support the Manager, Development Engineering and VP, Development with key project deliverables.
  • Support internal and regulatory inspections.

A successful Design Engineer will have:

  • Strong engineering design skills using SolidWorks CAD software.
  • Experience with 3D modeling software and report writing programs.
  • Adherence to risk-averse and compliant engineering documentation development and management criteria.
  • Strong motivation and self-management skills with the ability to work independently.
  • Analytical approach to understanding and communicating complex mechanical design principles.
  • Excellent communication skills, including detail-oriented technical writing capabilities and the ability to present with confidence to external and internal partners.
  • Excellent ability to collaborate and manage external CROs.
  • Ability to collaborate with legal on drafting and reviewing program-related contracts.
  • Desire to serve as a technical resource and subject matter expert to cross-functional teams.
  • Strong drive to achieve results, make recommendations, and pursue continuous improvement.
  • Ability to work collaboratively, with the judgment to know when to escalate for support.
  • Commitment to participating in and upholding an inclusive work environment.

To be considered for the position, you must have:

  • Bachelor’s Degree in an engineering discipline.
  • 3+ years of experience in the medical device industry, including experience in the SolidWorks CAD program (3D CAD, 2D Drawings, and TolAnalyst), product development, test method development and execution.
  • Proficiency in Word, Excel, PowerPoint, and statistical analysis software (JMP, Minitab, etc.).
  • Working knowledge of 21 CFR 820.
  • Working knowledge of the ISO 11608 series.
  • Ability to travel overnight up to 15%.

Additional preferred qualifications:

  • Mechanical, Biomedical, Chemical engineering degree preferred.
  • Medical device development experience, specifically auto-injector products, strongly preferred.
  • Experience in Predicative 6-Sigma Design and Critical Parameter Development & Management (CPD&M) preferred.
  • Preferred certifications/memberships: Six Sigma, International Organization for Standardization (ISO), Professional Engineer (PE) certification, American Society of Mechanical Engineers (ASME), Society of Plastics Engineers (SPE).

Please complete candidate application for consideration. Additional questions can be directed to talentacquisition@kaleo.com. 

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.