Full-Time

Production Operator 2

Posted on 8/8/2025

Surmodics

Surmodics

201-500 employees

Supplies IVD reagents and device coatings

Compensation Overview

$47.3k - $66.2k/yr

+ Bonus

Eden Prairie, MN, USA

In Person

Category
Medical, Clinical & Veterinary (1)
Requirements
  • Bachelor’s degree in a laboratory technology field (i.e. Chemistry, Biology) or 3+ years of production experience as a high level Chemical Operator/Technician (or equivalent)
  • 2+ years’ experience as Chemical Operator/Technician
  • Organizational and documentation skills and general problem solving ability
  • Good interpersonal skills and an ability to provide effective work direction
  • Excellent written and verbal communication skills
  • Computer skills appropriate for work responsibilities
Responsibilities
  • Manufacture product per SOP as directed by the production planner
  • Prepare and submit samples to the appropriate QC department
  • Ensure adherence to GMP guidelines for IVD manufacturing
  • Transfer and issue consumed raw materials to batches via the MRP system
  • Maintain thorough, up-to-date production & accounting forms
  • Review completed batch records for GMP/GDP compliance
  • Monitor inventory of raw materials
  • Train production personnel on relevant process and procedures
  • Monitor inventory of general laboratory supplies
  • Maintains laboratory equipment and document maintenance activities
  • Participate in the qualification/validation of new equipment
  • Oversee the routine housekeeping of the production area, cleaning process equipment, etc.
  • Keeping equipment on a preventative maintenance schedule
  • Write or edit standard operating procedures (SOPs) for repetitive manufacturing activities
  • Work with Quality Assurance to develop SOP’s required as part of the GMP process
  • Support the resolution of deviations, investigations, non-conformances, and other Quality issues

Surmodics provides components for in vitro diagnostics (IVD) and coatings for medical devices. Its IVD products include ELISA reagents, antigens, antibodies, and microarray slides that support sensitive immunoassays used to detect substances in samples, while its coatings include lubricious, hemocompatible, and drug-delivery options for devices like stents. The company differentiates itself by combining reagent supply with active collaboration on coating development and by offering design and production services for advanced balloon catheters, helping projects move to market faster. Its goal is to help customers bring diagnostic tests and coated medical devices to market efficiently.

Company Size

201-500

Company Stage

IPO

Headquarters

Eden Prairie, Minnesota

Founded

1979

Simplify Jobs

Simplify's Take

What believers are saying

  • PROWL data shows 94.8% blood flow restoration, driving Pounce adoption across 2-10mm vessels.
  • Pounce LP and Venous launches in 2025 expand addressable market to below-knee and venous thrombi.
  • Pulmonary embolism patent in April 2025 positions Surmodics for thrombectomy expansion.

What critics are saying

  • FTC blocks GTCR's $627M acquisition, starving R&D capital through 2026.
  • 8.1% amputation rate in PROWL triggers reimbursement denials by Medicare in 12 months.
  • Biocoat competes directly, eroding hydrophilic coating share by mid-2026.

What makes Surmodics unique

  • Pounce Thrombectomy Platform achieves 91.7% procedural success in PROWL Registry's 160 patients.
  • Mechanical-only clot removal without thrombolytics or aspiration sets Pounce apart.
  • Surmodics integrates 40-year coating expertise with proprietary vascular device manufacturing.

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Benefits

Performance Bonus

401(k) Company Match

401(k) Retirement Plan

Company Equity

Stock Options

Company News

Surmodics
Nov 4th, 2025
Surmodics Announces Outcomes from 160 Patients in PROWL Registry Evaluating Pounce(TM) Thrombectomy Platform in Treatment of Real-World Limb Ischemia Presentations

Surmodics announces outcomes from 160 patients in PROWL Registry evaluating Pounce(TM) Thrombectomy Platform in treatment of real-world Limb Ischemia presentations. Analysis of the all-comers PROWL Registry demonstrated high procedural success and safety in a cohort reflecting the real-world complexity of patients with symptomatic limb ischemia, over 40% of whom had symptoms lasting more than two weeks before intervention with the Pounce(TM) Platform. EDEN PRAIRIE, Minn.-(BUSINESS WIRE)-Nov. 4, 2025- Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that results from an analysis of 160 real-world patients with symptomatic infrainguinal limb ischemia from its PROWL registry study were presented on November 3rd at an industry-sponsored session at the 23rd Annual VIVA Conference in Las Vegas, NV. PROWL national co-principal investigators Dr. Sean Lyden and Dr. Joseph Campbell, and study investigator Dr. Peter Monteleone, presented the results. PROWL is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce(TM) Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry is collecting real-world efficacy and safety outcomes data for endovascular interventions using the fully mechanical, non-aspiration-based Pounce Thrombectomy Platform for up to 500 patients at up to 30 sites. The core lab-adjudicated study is enrolling all patients treated with the Pounce Platform, including those with shortened life expectancy, history of cancer or COVID-19, prior interventions to the target limb, and symptom duration up to and beyond 28 days. Most patients in the subset were treated with the Pounce Thrombectomy System, indicated for use in peripheral arteries 3.5-6 mm in diameter. The analysis examined subjects with symptomatic infrainguinal vessels followed through 30 days. The primary effectiveness endpoint, procedural success in target lesion(s) with or without adjunctive treatment, was 91.7%. The primary safety endpoint, incidence of device-related major adverse events (MAEs) from procedure to 30-day follow up, was 0.6% (N=1). The vast majority (94.8%) of patients experienced final core lab adjudicated post-procedural TIPI 2-3 blood flow restoration. Device technical success, restoration of blood flow to the target lesion(s) with <50% residual obstruction without the need of other therapies, was 83.2%. Average Pounce Platform use time in the study was 24.1 minutes with a median of 2 passes per patient. Core lab adjudicated procedural thrombus removal was complete or substantial in 94.1% of patients upon procedure completion. Previous studies of pharmacomechanical or aspiration thrombectomy for symptomatic limb ischemia only included patients with acute limb ischemia (symptom duration <=14 days).[1-3] In the 160-patient PROWL registry cohort, 43.1% of patients presented with >2 weeks of symptoms, a reflection of the heterogeneous clinical presentations seen in real-world treatment of peripheral ischemia.[4] In this diverse PROWL cohort of acute, subacute, and chronic thrombotic presentations, 78.8% of patients did not require adjunctive treatments (thrombolysis and/or thrombectomy) for clot removal following use of the Pounce Platform. Product use was well tolerated, with only 1 patient (0.6%) experiencing a device-related adverse event.* There were no reports of device related distal embolization. All-cause major adverse events at 30 days post-procedure were major amputation (8.1%, N=13), clinically driven target lesion revascularization (7.5%, N=12), and death (4.4%, N=7). There were no device-related deaths. "As reflected in the all-comers PROWL registry, a large share of PAD patients who require prompt removal of arterial blood clots have experienced symptoms well beyond two weeks," said Dr. Campbell. "The exclusion of these patients from other studies of peripheral arterial thrombectomy is a serious limitation, as thrombus becomes more organized with age and increasingly resistant to thrombolytics and aspiration-based devices. Findings from the PROWL registry show that the Pounce Thrombectomy Platform is an effective, rapid, low-risk option for front-line endovascular treatment of limb ischemia across the diverse populations we see in clinical practice." "Real-world thromboembolic patients present with numerous uncontrollable factors, including tremendous variability in lesion characteristics and locations, medical history, symptom duration, and urgency," said Dr. Lyden. "Data from the PROWL registry demonstrate that this device effectively addresses this variability, achieving rapid, efficient clot removal across a broad spectrum of clot chronicity and patient comorbidities. In nearly 80% of patients, no additional clot removal was required following use of the device, and procedural success exceeded 90%, outcomes that can translate to shorter procedure times, and reduced risk of complications." About the Pounce Thrombectomy Platform The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System, Pounce LP (Low-Profile) Thrombectomy System, and the Pounce XL Thrombectomy System. All are FDA-cleared, fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. They are indicated for use in peripheral arteries 3.5-6 mm, 2-4 mm, and 5.5-10 mm in diameter, respectively. Described as "grab-and-go" solutions, Pounce Thrombectomy Platform devices are both readily deployable and simple to use. The systems are composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body. Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention 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 modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company's mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics' website is not part of this press release or part of any filings that the company makes with the Securities and Exchange Commission. This press release contains forward-looking statements. Statements that are not historical or current facts, including the statements regarding the potential number of patients and sites for the PROWL registry study and Surmodics' growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the outcome of the full PROWL registry study, and the factors identified under "Risk Factors" in Part I, Item 1A of its Annual Report on Form 10-K for the fiscal year ended September 30, 2024, and updated in its subsequent reports filed with the SEC. These reports are available in the Investors section of its website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and Surmodics, Inc. undertake no obligation to update them in light of new information or future events. * Flow-limiting dissection followed by clinically driven target lesion revascularization Distal embolization requiring surgical procedure or obstructing one of the major downstream vessels >70% at the end of the procedure. * Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584-592. * de Donato G, Pasqui E, Sponza M, et al. Safety and efficacy of vacuum assisted thrombo-aspiration in patients with acute lower limb ischaemia: the INDIAN trial. Eur J Vasc Endovasc Surg. 2021;61(5):820-828. * Leung DA, Blitz LR, Nelson T, et al. Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry. J Endovasc Ther. 2015;22(4):546-557 * Howard DP, Banerjee A, Fairhead JF, Hands L, Silver LE, Rothwell PM. Population-based study of incidence, risk factors, outcome, and prognosis of ischemic peripheral arterial events: implications for prevention. Circulation. 2015;132(19):1805-1815. View source version on businesswire.com: https://www.businesswire.com/news/home/20251104485358/en/ Surmodics Public Relations Inquiries: [email protected]

Surmodics
Oct 27th, 2025
Surmodics Announces PROWL Registry Sex-Specific Data to be Presented at TCT Conference on October 28

Surmodics announces PROWL Registry sex-specific data to be presented at TCT conference on October 28. October 27, 2025 at 4:05 PM EDT PROWL Registry evaluates the Pounce(TM) Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Results of a sex-specific analysis of 160 patients with symptomatic infrainguinal vessels will be shared. EDEN PRAIRIE, Minn.-(BUSINESS WIRE)-Oct. 27, 2025- Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that Dr. Peter Monteleone will present data from a sex-specific analysis of 160 patients in the PROWL registry with symptomatic lower extremity (infrainguinal) vessels treated with the Pounce(TM) Thrombectomy Platform. The presentation will be held on Tuesday, October 28th at the 37th Annual TCT Symposium in San Francisco, California. TITLE: Results of a Novel Percutaneous Mechanical Arterial Thrombectomy Device in Lower Extremity Ischemia: Sex-Specific Analysis DATE: Tuesday, October 28 TIME: 12:40 PM (PDT) VENUE: Moscone Center, Station 3, Halls B-C Peter Monteleone, MD, an investigator in the PROWL registry, is an interventional cardiologist and associate professor in the Department of Internal Medicine at the Dell Medical School, University of Texas at Austin. He serves as the director of the Ascension Seton Heart Institute Clinical Research Group and medical director for the SHI Vascular Imaging Laboratory. Dr. Monteleone has participated in multiple clinical trials. About the PROWL registry PROWL is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce(TM) Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry is collecting real-world efficacy and safety outcomes data for endovascular interventions using the fully mechanical, non-aspiration-based Pounce Thrombectomy Platform for up to 500 patients at up to 30 sites. The core lab-adjudicated study is enrolling all patients treated with the Pounce Platform, including those with shortened life expectancy, history of cancer or COVID-19, prior interventions to the target limb, and symptom duration up to and beyond 28 days. The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System, Pounce LP (Low-Profile) Thrombectomy System, and the Pounce XL Thrombectomy System. All are FDA-cleared, fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. They are indicated for use in peripheral arteries 3.5-6 mm, 2-4 mm, and 5.5-10 mm in diameter, respectively. Described as "grab-and-go" solutions, Pounce Thrombectomy Platform devices are both readily deployable and simple to use. The systems are composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body. Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention 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 modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company's mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics' website is not part of this press release or part of any filings that the company makes with the Securities and Exchange Commission. This press release contains forward-looking statements. Statements that are not historical or current facts, including the statements regarding the potential number of patents and sites for the PROWL registry study and regarding Surmodics' growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the outcome of the full PROWL registry study, and the factors identified under "Risk Factors" in Part I, Item 1A of its Annual Report on Form 10-K for the fiscal year ended September 30, 2024, and updated in its subsequent reports filed with the SEC. These reports are available in the Investors section of its website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and Surmodics, Inc. undertake no obligation to update them in light of new information or future events. View source version on businesswire.com: https://www.businesswire.com/news/home/20251027578893/en/ Surmodics Public Relations Inquiries: [email protected]

Swanson Reed
May 6th, 2025
Minnesota Patent of the Month - April 2025

Surmodics MD, LLC has introduced a groundbreaking solution for pulmonary embolism treatment with its newly patented technology.

MyChesCo
Apr 20th, 2025
FTC Expands Lawsuit Against GTCR's $1.75B Surmodics Acquisition

The FTC, joined by Illinois and Minnesota, has expanded its lawsuit against GTCR over its proposed $1.75 billion acquisition of Surmodics. The complaint argues that the merger would create a dominant player in the market for outsourced hydrophilic coatings, crucial for medical devices, by eliminating competition between Surmodics and Biocoat, Inc., in which GTCR holds a majority stake. This could lead to higher prices, reduced innovation, and lower quality in medical tools.

URALLNEWS
Apr 4th, 2025
Surmodics launches Pounce XL thrombectomy system

Surmodics launches Pounce XL thrombectomy system.

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