Manufacturing Engineer at Surmodics

Ballinasloe, County Galway, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Engineering Degree or equivalent
A minimum of 3 years’ engineering experience working in a similar role
Balloon manufacturing and polymer processing knowledge highly desirable
Strong technical understanding of set up and maintenance of balloon manufacturing processes
Experience in validation, equipment design and Lean Manufacturing highly desirable
Proven technical expertise and competence across all aspects of manufacturing engineering function including lean
Demonstrated expertise and detailed knowledge of the medical device industry
Equipment Procurement and Validation experience
Has conducted IQ/OQ/PQs and/or validations previously in a regulated environment
Effective knowledge of the regulatory environment in which the business operates
Proven written and oral communication skills and an ability to prepare competent business cases
An analytical approach to problem solving
Good oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies
Is creative, continually learning and exploring new ideas
High level of flexibility required with regard to role and prioritisation of activities
A self-starter applies his/her own initiative in most situations
A good team player who works well in a team environment
Capacity to maintain the highest levels of confidentiality internally and externally
Ability to stay connected to multiple projects simultaneously

Responsibilities

Provide technical support on all product and processing related issues
Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved
Apply “Lean” principles to production considering flow optimisation, throughput time, product movement, layout, and space
Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment
Set up Preventive Maintenance and Calibration routines
Provide ongoing day to day support to Balloon Forming production; continually seeking to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot production related issues, implementing “robust permanent fix” solutions
Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Work Instructions, Manufacturing procedures and Logs
Manage Tooling and Equipment spare parts inventory to support manufacturing capacity
Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations
Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective

Skills

Lean principles

Manufacturing processes

Equipment validation

Factory Acceptance Testing

Preventive Maintenance

Calibration

Troubleshooting

pFMEAs

TMVs

Balloon Forming

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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