Senior Sustaining Engineer at Surmodics

Eden Prairie, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Four-year technical degree with minimum 5 years’ experience in a Quality Engineering role or similar
ASQ Quality Engineering certification desired
Experience and training in process and equipment validation
Extensive experience with QSR and ISO quality systems
Extensive experience with statistical techniques, measurement/trending and SPC tools
Strong attention to detail
Proficient computer skills - Microsoft Word, Access and Excel, statistical software (JMP, MINITAB)

Responsibilities

Provide technical expertise in design controls and risk management (Product Development, 20-30%)
Develop risk management plans and lead cross-functional risk management activities (Product Development, 20-30%)
Draft documents and provide technical review for document revision, review and approval (Product Development, 20-30%)
Maintain design history file and lead design review discussions (Product Development, 20-30%)
Support design transfer activities including new equipment qualification (Product Development, 20-30%)
Support the investigation and resolution of issues related to supplied raw materials and services (Purchasing & Supplier Controls, <5%)
Lead efforts to assess and qualify new or changed supplied raw materials (Purchasing & Supplier Controls, <5%)
Drive/support engineering activities for design and/or process changes to existing products by troubleshooting identified issues using good engineering practices, developing evidence-based project plans, and executing on deliverables (Continuation Engineering, 70-80%)
Implement opportunities to optimize/improve manufacturing processes and systems (Continuation Engineering, 70-80%)
Ensure strong cross-functional collaboration, timely multi-disciplinary input and compliance with regulatory standards and internal quality system requirements (Continuation Engineering, 70-80%)
Lead cross-functional activities for completion of risk management deliverables when changes are required; Perform risk management assessment for changes (Continuation Engineering, 70-80%)
Analyze and execute engineering change control efforts per established processes and manage the deliverables per QMS requirements (Continuation Engineering, 70-80%)
Analyze customer change notification requirements to support internal process changes (Continuation Engineering, 70-80%)
Lead discussions with customers to address quality issues and change notifications (Continuation Engineering, 70-80%)
Support product stability programs by reviewing protocols and reports (Continuation Engineering, 70-80%)
Perform root cause investigations, propose corrective actions and oversee their implementation by using problem solving tools (Continuation Engineering, 70-80%)
Support complaint investigation efforts as needed, including returned product evaluation (Continuation Engineering, 70-80%)
Develop and maintain key quality metrics (Continuation Engineering, 70-80%)
Provide technical support to project teams (Validation, <5%)
Draft and approve protocols and reports (Validation, <5%)

Skills

Key technologies and capabilities for this role

Design ControlsRisk ManagementDesign History FileDesign TransferEquipment QualificationSupplier QualificationTroubleshootingProcess OptimizationDesign Review

Questions & Answers

Common questions about this position

What are the main responsibilities of the Senior Sustaining Engineer?

The role focuses primarily on continuation engineering (70-80%) for existing products, including troubleshooting issues, optimizing manufacturing processes, managing engineering changes, and ensuring regulatory compliance. Additional duties include product development support (20-30%) like design controls and risk management, and minor purchasing controls.

What skills are essential for this position?

Key skills include expertise in design controls, risk management, troubleshooting engineering issues, process optimization, cross-functional collaboration, and compliance with regulatory standards and quality systems.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Senior Sustaining Engineer role?

A strong candidate excels in assessing business and customer needs and risks in a fluid environment, with the ability to lead cross-functional teams, drive continuous improvements, and manage design and process changes effectively.

Surmodics

Provides components for diagnostics and medical devices

About Surmodics

Surmodics specializes in providing essential components for in vitro diagnostic (IVD) products and advanced coatings for medical devices. Their IVD offerings include a variety of products such as protein stabilizers, diluents, blockers, substrates, and antibodies, which are vital for creating sensitive immunoassays that detect substances in biological samples. Surmodics also develops advanced coatings for medical devices, including lubricious and hemocompatible coatings, and is known for creating the drug delivery coating for the first drug-eluting stent. The company collaborates closely with clients to accelerate product development and commercialization, which helps them meet market demands quickly. Surmodics stands out from competitors through its strong focus on client collaboration and rapid product development, aiming to support the healthcare and biotechnology sectors effectively.

Eden Prairie, MinnesotaHeadquarters

1979Year Founded

$125MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

401(k) Company Match

401(k) Retirement Plan

Company Equity

Stock Options

Risks

GTCR acquisition may disrupt operations or client relationships.

Becoming privately held could reduce transparency and investor confidence.

New thrombectomy systems face competition, potentially impacting market share.

Differentiation

Surmodics excels in advanced coatings for medical devices, enhancing device performance.

The company offers a comprehensive range of IVD products for sensitive immunoassays.

Surmodics' expertise in drug-delivery coatings is unmatched, proven by the first drug-eluting stent.

Upsides

Surmodics' acquisition by GTCR could accelerate growth and innovation.

The launch of Pounce Thrombectomy Systems addresses rising peripheral artery disease cases.

Surmodics' SurVeil DCB shows promising results, boosting its vascular intervention portfolio.

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