Med Device Scientist II

This Scientist II role supports the development and optimization of drug delivery systems for combination products used in preclinical and clinical studies. You will work as part of a multidisciplinary R&D team to design and execute laboratory experiments, characterize the physicochemical properties of drug substances, analyze data, and document results to support product development and regulatory submissions.

Responsibilities

• Apply established scientific methods to formulation and drug delivery challenges and assist in evaluating technical approaches under the guidance of team members.
• Plan and execute laboratory experiments, including analytical testing such as drug assay, degradant analysis, and other physicochemical characterization using established methods.
• Perform analytical techniques such as HPLC, UPLC, GC, LC/MS, GC/MS, UV-Vis, DSC, TGA, or NMR.
• Assist with analytical method development, qualification, and validation activities as needed to support product and process development.
• Characterize physicochemical properties of drug substances, including physical form, stability, solubility, and drug–excipient interactions.
• Support release and stability testing activities by coordinating with internal and external laboratories and ensuring accurate documentation of results.
• Prepare clear, well-organized technical documentation and data packages to support regulatory submissions, design history files, and other product development documentation.
• Participate in cross-functional product development teams, collaborating with formulation scientists, analytical scientists, manufacturing, quality, regulatory, and other functional groups to achieve project objectives.
• Identify opportunities for laboratory, experimental, or process improvements and contribute ideas that enhance efficiency, quality, and technical capability.
• Communicate technical findings effectively through written reports, presentations, and discussions with project teams and stakeholders.
• Maintain laboratory records, experimental data, and documentation in compliance with applicable quality system requirements, laboratory procedures, and safety practices.
• Follow all quality system requirements and demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Requirements

• Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, or a related technical field.
• Familiarity with analytical techniques such as HPLC, UPLC, GC, LC/MS, GC/MS, UV-Vis, DSC, TGA, or NMR.
• Understanding of analytical method development, qualification, or validation, especially for drug release, stability testing, or physicochemical characterization.
• Experience working within a regulated environment such as FDA, ISO, GMP, or GLP through academic or industry research.
• Knowledge of controlled drug delivery systems and their application in combination products.
• Exposure to pharmacokinetic/pharmacodynamic (PK/PD) studies or preclinical model development.

Work Environment

You will work in a laboratory-based R&D environment focused on developing interventional therapies for cardiovascular and related conditions. The role involves regular hands-on wet lab work with chemicals, drug substances, and excipients, as well as operation of analytical instrumentation such as chromatographic and spectroscopic systems where applicable. Work is conducted within a regulated framework that emphasizes compliance with quality system requirements, including FDA, ISO, GMP, or GLP standards as applicable. You will collaborate closely with scientists and professionals from formulation, analytical, manufacturing, quality, and regulatory functions in a cross-functional, project-driven setting. The environment emphasizes patient safety, product quality, and continuous innovation, with structured documentation practices and adherence to laboratory safety procedures and guidelines.

Job Type & Location

This is a Contract to Hire position based in Maple Grove, MN. The role is fully onsite.

Pay

The pay range for this position is $30.00 - $40.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short-term and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)