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Senior Process Engineer

Company: SurModics
Location: Eden Prairie
Posted on: April 8, 2021

Job Description:

Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions. 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. A Senior Process Engineer in our Engineering Department would be expected to: Responsibilities

  • Leads the development and characterization of pilot-scale manufacturing processes
  • Prepares detailed experimental plans and coordinates execution with technical team members
  • Reviews experimental data and provides statistical and other technical analysis
  • Considers experimental outcomes, project and manufacturing objectives, and recommends next steps
  • Supports vendor and other external process qualification
  • Assures readiness for pilot-scale manufacturing and clinical builds
  • Supports the transfer and validation of manufacturing processes Communicates throughout organization (30%)
    • Communicates experimental plans, outcomes, and recommendations to project team and R&D leadership
    • Prepares clear, concise, and accurate technical reports and laboratory notebook records
    • Assists with patent and regulatory filings Maintains an organized and effective manufacturing environment (20%)
      • Plans and recommends equipment and facility needs to support R&D projects
      • Leads the design, build, and qualification of manufacturing equipment, tools, or facility space
      • Leads efforts to improve laboratory or manufacturing procedures or methods Quality Assurance and Safety Responsibilities
        • Performs responsibilities in compliance with the quality systems as described in SurModics' Quality Manual.
        • Adheres to all company safety, health and hygiene policies, procedures, and directives, including neatness of lab bench and general use areas. Skills and Experience
          • BS or advanced degree in engineering or related discipline
          • 5+ years overall process development experience
          • Medical device or pharmaceutical process development experience preferred
          • Demonstrated ability in process characterization and experimental design
          • Strong engineering and problem solving skills
          • Ability to verbally communicate technical plans and outcomes
          • Strong skills in the preparation of written technical reports 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. Are you legally authorized to work in the US? --*
            -- Do you require sponsorship now or in the future? --*
            -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Surmodics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. 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. Gender Please select Are you Hispanic/Latino? Please 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 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. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, 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? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
            • Autism
            • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
            • Blind or low vision
            • Cancer
            • Cardiovascular or heart disease
            • Celiac disease
            • Cerebral palsy
            • Deaf or hard of hearing
            • Depression or anxiety
            • Diabetes
            • Epilepsy
            • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
            • Intellectual disability
            • Missing limbs or partially missing limbs
            • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
            • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . 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.

Keywords: SurModics, Eden Prairie , Senior Process Engineer, Engineering , Eden Prairie, Minnesota

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