Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

Job Summary

This position supports medical device coating services for Surmodics customers.  The technician position will be responsible for the handling of medical devices and the coating of medical devices with Surmodics proprietary polymers.

Responsibilities

Manufacturing (% Varies)

• Prepare and inspect materials for coating operations
• Perform Dip Coating operations and verification activities
• Perform Curing operations and verification activities

 Manufacturing Support (% Varies)

• Measure dimensions of material to verify conformance to specifications
• Visually inspection materials to ensure quality of raw and finished medical device products
• Read procedures to determine product specifications or material requirements
• Record operational or production data in accordance with Good Documentation Practices to ensure quality
• Label or mark production or equipment with identifying information
• Train technicians on certified operations
• Reconciliation of batch records

Business Strategy (% Varies) 

• Assist coating engineers with feasibility activities
• Review procedures and provide feedback on feasibility to be performed until commercial release requirements

Minimum Qualifications

• High School Diploma or equivalent
• 2+ years Medical Device manufacturing experience
• Good Documentation Practices experience
• Research and Development production experience
• Intermediate computer skills
• Strong written and verbal communication skills
• Strong attention to detail
• Good interpersonal skills
• Ability to read and interpret documents

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.

Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Seeking Talent Near: Minneapolis, MN; Saint Paul, MN; Fargo, ND; Sioux Falls, SD; Omaha, NE; Billings, MT; Boise, ID

Position Summary

Primary Responsibilities

• Build and sustain strong relationships with national and regional medical and scientific thought leaders, patient advocacy groups, and centers of excellence aligned to Acadia’s Medical Affairs strategy
• Engage key opinion leaders in meaningful scientific exchange, research discussions, and education on current and emerging therapies
• Support clinical research activities, including trial site engagement and cultivation and facilitation of investigator-initiated research proposals
• Develop and maintain deep scientific, clinical, and therapeutic expertise across Acadia’s portfolio
• Collaborate cross-functionally, in compliance with all guidelines, with Regional Business Leaders and Account Business Managers to support aligned field execution
• Provide strategic field insights that inform Medical Affairs and broader organizational decision-making
• Identify disease state insights and compound attributes that contribute to product differentiation and scientific value
• Deliver high-quality scientific, clinical, and educational support to internal stakeholders and external healthcare partners
• Represent Acadia at medical meetings, congresses, educational programs, and support Commercial activities including speaker and sales training
• Perform other duties as assigned

Education/Experience/Skills

• Advanced scientific degree (MD, PharmD, or PhD) in a relevant discipline
• Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with hands-on scientific or medical affairs responsibilities
• Prior Medical Science Liaison experience within a field-based medical affairs role
• Demonstrated scientific and clinical expertise, with experience in rare diseases, epilepsy, neurology, or psychiatry
• Strong working knowledge of regulatory, compliance, and clinical considerations impacting pharmaceutical and managed care environments
• Proven ability to communicate complex scientific and drug information to healthcare professionals and internal stakeholders
• High proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint
• Ability to travel up to 75% of the time, with residence within the assigned territory

Position levels:

• Medical Science Liaison: $139,600 - $174,500 requires an advanced degree (MD, PharmD, PhD) in a scientific discipline, 5 years of progressively responsible experience in the medical, clinical, and/or pharmaceutical field
• Sr. Medical Science Liaison: $176,000 - $220,000 requires an advanced degree (MD, PharmD, PhD) in a scientific discipline, 7 years of progressively responsible experience in the medical, clinical, and/or pharmaceutical field, including 3 years as an MS

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-REMOTE

#LI-CS1

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Job Responsibilities:

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

Educational Requirements & Work Experience:

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Travel required: up to 25%

A reasonable estimate of the base salary compensation range is $95,000 to $125,000 and cash bonus. #LI-IB1