Hire Power Associates

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04/24/2019

A small, stable Medical Device firm in metrowest- Boston is making a critical hire.

They have developed a breakthrough medication dosing/delivery system for pharmaceutical manufacturers and laboratories and are being endorsed as the delivery system of choice by regulatory authorities.

This is a tight knit group devoted to technical excellence & maintaining a sane work/life balance.

This will be the Senior Mechanical Engineering resource…. a hands-on Product Development Engineer & Project Lead (BS/MSME) who will drive the creation of an automated instrumentation platform comprising motion control, opto-electro-mech HW/SW/Firmware, sensors & electronics – Motors, actuators, drivetrains/bearings & machine vision elements.

They need a mature communicator & technical leader who has delivered products from concept stage to commercial release. To oversee in/external resources and serve as a mentor/leader.

Advanced SolidWorks skills are required, as is knowledge of molding/forming/machining fabrication processes of plastics & metals.

Primary responsibilities include:
· Advanced conceptual and detail designs for complex systems
· Tend to big picture architecture design AND details of troubleshooting E/M subsystems
· Prototype development/design/testing/analysis – simulation/performance analyses/root cause diagnostics
· Produce/conduct feasibility studies – including generation of well documented test plans.
· Develop/define best design/test practices
· Manage new product development BOMs and provide Eng'g. interface for Mfg. operations.
· Coordinate design, construction & implementation of test fixtures for production
· Additive manufacturing processes

Only Permanent Residents or US Citizens will be considered for this position

Please sends your CV and a short note indicating why you believe you're the best candidate for this position to:

Neil Rauch, President
ire Power Associates
410-318-6737 / 978-808-9898 ©
[email protected]

Matching exceptional candidates
with discerning clients for 30+ years.

04/09/2019

Sr Mechanical Engineer
Generate specs based on requirements, take designs from concept (DFM) to production, and oversee test/release of commercialized products. Calls for creative component & system level design. Work with little guidance. Strong SolidWorks (w/3D modeling + dimensioning). BS/MSME – 7+years. GD&T (Y14.5)

Skills:

• Dimensioning and tolerancing structural steel/sheet metal
• Efficiently read and check engineering drawings
• Complete assembly tolerance stacks
• Minimal Travel (0-15%) – Divisions in Spain, Italy, Israel
• Close-tolerance, high-precision machining, thermal cycling - material selection, and machining (forming, welding, casting, plating)
• Have developed project objectives, schedule, and product performance specs
• Have resolved component/system level issues
• Create/maintain documentation of concepts, designs, drawings & processes.
• Can perform tolerance stacks to ensure system performance

An ideal candidate will have:

• Digital printing; hybrid & roll-to-roll; media transport systems
• High accuracy motion control systems: rotary, linear, multi-axis Cartesian, etc.
• Some automation & mechatronics
• 3D printing, rapid prototyping
• Excellent presentation skills including oral and visual communication
• A great attitude and strong desire to work as a cross-functional team member

04/09/2019

Senior Mechanical Engineer/Product Development
Multi-disciplinary product development team to create, design, implement, test and deliver innovative instrumentation technology and automation solutions for characterizing aerosol and spray drug products.

Our technology platform combines motion control, opto-mechanical hardware, sensors, electronic PCBs, software and firmware into standard setting instruments used by regulatory authorities, pharmaceutical companies, contract laboratories and other organizations around the world.

Must have a strong work ethic, engineering acumen, proven builder of complex low volume products

Can think from big picture design architecture down to details of troubleshooting E/M subsystems and anything in between to get the job done.

• Team player/small-team environment - product development, product mgt, marketing, mfg & tech support to define requirements/specs, manage project scopes, deliver relevant work products, enhancements, and utilities for customer success.
• Produce advanced conceptual and detail designs for complex system mechanics/hardware and prototype those designs as needed.
• Be an active organizer, participant, and leader of design reviews.
• Produce/conduct feasibility studies – generate well-documented test plans.
• Manage new product development BOMs. Provide Engineering interface for Manufacturing operations.
• Develop/define best design practices for development/test: use simulation modeling, functional testing etc.
• Help manage projects - provide technical oversight for in/external resources.
• Coordinate design/construction/implementation of test fixtures for production
• Act as vendor liaison to support technology suppliers as required.
• Lead/manage/Mentor engineers.

Competencies:
• Opto-electro-mech product design - motors, actuators, drivetrains/bearings, machine vision, motion control.
• SolidWorks - Certified Expert - highly desirable.
• Expertise with additive manufacturing technologies and factoring them into production components.
• Expertise in processes for metals and plastics: CNC machining/turning, sheet metal, molding, thermoforming, plastic and metal fabrication methods.
• Deliver cost-effective, cross-discipline designs - motion, vision, mechanical, electronic, controls, and fluid flow elements with functional, thermal, static and dynamic performance analyses.
• Outstanding communications skills – diagram on white boards; write detailed specifications documents.
• Proven expertise with first principles analyses and root cause diagnostics at the systems level.
• Track record of delivering on product development projects from concept stage to commercial release.
• Has both theoretical & practical experience – hands-on in a lab environment; exp. using basic equipment.
• Energetic problem-solver/results-driven, with excellent time-mgt, planning/org/written/verbal skills.

Qualifications:
• BS/MSME - 5+ years system development experience - advanced knowledge of mechanical design.
• Significant prototype development/testing - hardware design and analysis.
• Devise solutions for unique and complex problems.
• Can reprioritize and change direction depending on emergent requests.
• Prior mgt/oversight/delivery of multiple projects on budget and schedule.
• Advanced comm skills - present concepts/ideas in a clear/coherent manner
• Experience in an internationally recognized quality mgt system (ISO9001).
• Minimal, if any travel. (Should have passport/driver’s license)
• Exemplifies discretion, integrity and a strong sense of work ownership.

04/09/2019

Sr. Quality Engineer - Support Product Development team. Validate/verify Design Control for drug-delivery devices: Design Verif./Valid., and Design Transfer efforts; ensure requirements are met.

• Write/coordinate development & implementation of new/updated Quality System procedures for ISO/QSR: verif./valid. protocols, manufacturing procedures, product & material specs, design/development documentation, SOPs, and development & task force projects
• Support 510(K) filing for new products
• Support launch of approved devices: Technology transfer from development to commercialization from a Quality/Manufacturing perspective
• Facilitate ex*****on of Risk Mgt and Usability Engineering process activities
• Develop statistically-based sampling plans for incoming, in-process and final testing and inspections, and process validations
• Lead new supplier qualification & assessment of finished goods, components, raw materials & services
• Work with in/external inspection resources to fulfill incoming inspection requirements for device components
• Work with project teams to develop statistically sound tests (DOE) to support results
• Develop, review & approve validations and completion reports for new and existing products, processes and equipment
• Apply statistical analysis to support data-driven decision making
• Ensure all projects comply with GMP, QSR, ISO or other requirements
• Participate in FDA inspections, ISO Certification; oversee audits and customer audits
• Identify/implement continuous improvements in product quality/ quality system
• Interact with & coordinate activities with other departments, external vendors and customers
• Lead root cause analyses of failure investigations – Lead/support Corrective & Preventative Action(s) implementation and/or review
• Reports to QA Manager.

Min Reqs:
• BS/MS ME/IE/Mfg Eng -4-6 yrs in a QE/QA role (medical device/pharma mfg)

Ideal
• Prior product development projects in the medical device industry
• 510(k) submissions and/or FDA inspections
• Expertise in risk management per ISO 14971
• MS Office Suite, statistical sampling & analysis tools (inc. Minitab)
• Six Sigma Green/Black Belt Certification
• Excellent organizational, verbal and written communication skills

10/22/2013

Control Systems/Automation Engineers

How about considering working for a leading developer of sensors, controls & software that sense, measure and report particulates produced by a diverse range of manufacturing operations .

Automation Engineer (Location – North Shore / Boston)
Design & support current control system and HMI/SCADA offerings while improving/productizing new solutions. Help integrate automation solutions with IoT and advanced remote customer service initiatives.

• Become knowledgeable and skilled on the company’s core product lines and applications
• Design and develop value-added HMI/SCADA applications based on project requirements & application strategy (Wonderware, Ignition, Open Automation or Factory Talk experience a plus)
• Design and develop PLC solutions (Allen-Bradley/Siemens)
• Work with design engineering to support the development of Auburn FilterSense products as related to integration/communication with third party HMI/SCADA and PLC solutions
• Produce electrical schematics, drawings and all project documentation
• Provide system integration engineering for customers pre/post-sale inc. fieldbus communications support
• Provide high level technical support for installation, commissioning and training for both HMI/SCADA solutions and the company’s core product lines
• Help improve internal processes for high level quality control/ISO 9001
• Assist in expanding in-house control panel manufacturing capabilities
• Become technically versed with and provide application support for all company controls and monitors

REQUIREMENTS

• BS in Engineering
• 2-15+years experience with HMI/SCADA/PLC’s, and control system design
• Allen-Bradley (Control Logix, Compact Logix, PanelView Plus), equivalent Siemens products and ind. comm. networks (Ethernet IP, Modbus TCP, Profibus etc. is preferred.
• Factory Talk, Wonderware, SQL and Visual Basic/C #/Java is a plus.
• Excellent written/verbal communications skills and high attention to detail
• Hands-on, outgoing personality and interest for sales/customer interaction
• A flexible, positive team player; able to multi-task and contribute across disciplines
• Learn quickly and independently
• Travel 25%-35% (North America, some international)

This is a small company (div. of a larger one) with a congenial workplace environment that is experiencing 50% growth for the second year.

10/22/2013

Product Engineer - Industrial Instrumentation/Controls
Smart sensing & intelligent control solutions.
Growth-oriented role - become a product specialist, understanding technology, applications & markets - apply that knowledge to customers and internally. Growth opportunities span product engineering, technical support, sales/applications engineering, automation engineering (HMI/PLC design & programming) and longer term product management.

•Provide application solutions - support customers/sales channels w/sensors, controls & software solutions
•Work closely with sales engineering to assist with quotes and close sales
•On-site support for customer startups/training; collect, analyze & report on data
•Remote/on-site support for automation solutions/plant system integration & communications
•Produce and update operating manuals/tech support and marketing materials
•Produce documentation QC for specifications and for sales/marketing objectives
•Assist engineering with field work for product updates and product development
•Visit customer sites and sales channels for training and trials/demonstrations

Requirements

•Assertive / hands-on / outgoing - Combine tech skills and motivation for product mgt/marketing and sales/customer interaction
•2–10 years / BS in Engineering
•Ideally process instrumentation, PLCs, or HMI/SCADA software expertise
•Experience with air pollution control systems or EPA regulations a plus
•Excellent computer/written/verbal skills and high attention to detail
•Team player able to multi-task and contribute across disciplines
•Motivated to learn quickly and independently
•15%-30% travel (N. America (possible international)

Address

6117 Benhurst Road
Baltimore, MD
21209

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