Principal R&D/Product Development Engineer at Surmodics

Eden Prairie, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree in engineering or related technical field
7 years related work experience
Ability to apply analytical skills and technical principles to problem solving and product development
Good written and verbal communication skills
Performs work with minimal supervision, in a timely manner
Strong interpersonal and organizational skills and the ability to work effectively as a team member
Familiarity with statistical techniques
Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, database, and other applicable software programs
Working knowledge of common lab equipment (caliper, micrometer, tensile tester, pressure tester, vision measurement system) and knowledge of lab practices and techniques
Working knowledge of United States and international standards as applicable to the department

Responsibilities

Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization
Accurately and efficiently translates user and patient needs into verified/validated devices, through creation and refinement of design requirements, design specifications, and test method, and procedures while adhering to design controls best practices
Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements
Owns verification and validation activities through regulatory clearance and design transfer
Manage multiple projects and maintain on-schedule while serving as the primary point of contact for management for those projects
Drives design reviews and ensures on time completion of design control deliverables
Design, assemble and evaluate prototype device assemblies in order to assess technical feasibility of various solutions
May be responsible for direct reports, including reinforcing the open-door policy and ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood
Actively identifies systemic department and organizational improvements as well as product portfolio expansion opportunities; helping to refine our product development strategy and roadmap
Interface with physicians and other medical personnel in a professional manner (maintaining confidentiality and intellectual property vigilance)
Contribute to design/development of product line extensions and product improvements
Author protocols and reports including engineering studies using basic statistical methods
Communicate with outside suppliers for component sourcing and refinement
Develop and own true clinical expertise around clinical/market focus area including: entirety of disease condition, relevant anatomical and systemic knowledge, medical management, surgical, and interventional treatment options, relevant product & procedural treatment options, overall clinical risk vs. benefit assessment

Skills

Key technologies and capabilities for this role

Medical Device DesignProduct DevelopmentPrototypingTest Method DevelopmentDesign FixturesDesign VerificationDesign ValidationRegulatory ClearanceDesign ControlsProject ManagementCross-functional TeamsDesign Reviews

Questions & Answers

Common questions about this position

What are the minimum qualifications for this role?

Candidates must have a Bachelor’s degree in engineering or related technical field and 7 years of related work experience.

What salary or compensation does this position offer?

This information is not specified in the job description.

Is this a remote position, or is there a location requirement?

This information is not specified in the job description.

What does the team structure look like for this role?

The role may involve responsibility for direct reports, acting as a leader for cross-functional development teams, and serving as the primary technical contributor.

What makes a strong candidate for this Principal R&D Engineer position?

Strong candidates will have a Bachelor’s degree in engineering, 7+ years of experience, and the ability to lead projects from concept to commercialization while managing cross-functional teams and adhering to design controls.

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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